DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Status of the claims
Claims 1-19, 34-35, and 38-47, are pending. Claims 20-33 and 36-37 have been cancelled.
Claims 1-4, 10-14, and 38-47, directed to the elected Species of Group I (Figs. 2-9), are examined as detailed herein below.
Claims 5-9, 15-19, and 34-35, directed to the non-elected Species of Group II, are withdrawn.
Claim Objections
3. Claims 1 and 10 are objected to because of the following informalities:
In both claim 1 and claim 10, at the end of step i), each claim recites “of the patient of the patient” which is a typographical error of duplicative “of the patient”.
In both claim 1 and claim 10, in step i), “a hard palate” should be “[[a]] the hard palate”.
In claim 10, at the end of step iii), the comma has been striked-through/deleted, leaving the clause without an ending punctuation.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
4. 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.
5. Claims 1-3, 10-13, and 38-47, are rejected under 35 U.S.C. 103 as being unpatentable over Sato et al. (US 2019/0021817) in view of Hamm (US 2021/0007831).
Regarding claim 1, Sato et al. discloses a method for repositioning teeth of a patient, comprising: providing at least one appliance 800 or 900 (Figs. 8-9) specific to the patient for placement in the patient's mouth during use, wherein the at least one appliance 800 comprises a polymeric shell 802/806 having a cavity 802 shaped to receive teeth of the upper jaw of the patient; the polymeric shell 802/806 integral to a polymeric segment 806 shaped to cover the hard palate of the upper jaw of the patient (see Figs. 8-9; paragraph [0064].
Similar to the appliance 800 in Fig. 8, Sato discloses appliance 900 in Figs. 9A-9B comprising polymeric shell 902/906 having cavity 902 shaped to receive teeth and integral segment 906 shaped to cover the hard palate of the upper jaw (see Figs. 9A-9B). Sato et al. further discloses: geometry of the shell 902/906 is configured such that the at least one appliance adjusts position of the teeth of the upper jaw of the patient during use (paragraph [0065] “push out the anterior teeth… distalize the posterior teeth”, and wherein geometry of the segment 906 is configured such that the at least one appliance contacts the hard palate and applies forces to the hard palate to adjust position of the hard palate of the upper jaw of the patient during use (see Figs. 9A-9B; paragraph [0065] “feature 906 that is sized and shaped to conform to and exert pressure against the hard palate”).
Sato et al. discloses the geometry of the segment and the geometry of the shell for the at least one appliance are derived from a three-dimensional model of the surfaces of the teeth and hard palate of the upper jaw of the patient (Fig. 11); and
wherein the three-dimensional model of the surfaces of the teeth and hard palate of the upper jaw of the patient is generated by:
i) generating an initial three-dimensional model representing surfaces of the teeth and a hard palate of the upper jaw of the patient of the patient (see Fig. 11; steps 1100-1102, paragraph [0020] “generating a model of the patient’s teeth, gingiva, and palate… using the received data”),
ii) isolating a tooth part of the initial three-dimensional model which corresponds to surfaces of at least one tooth of the upper jaw of the patient (Sato et al. paragraph [0021] “each tooth is a separate object… in the digital model”),
iii) moving the isolated tooth part of the initial three-dimensional model (Sato et al. paragraph [0021] “each tooth is a separate object that can be independently moved in the digital model”),
iv) isolating a palate part of the initial three-dimensional model which corresponds to surfaces of the hard palate of the upper jaw of the patient (paragraph [0021] “the palate and/or gingiva is also a separate object”), and
v) moving, stretching, or otherwise transforming the isolated palate part of the initial three-dimensional model such that the geometry of the segment of the particular appliance is configured to move the hard palate upward and/or forward during use (paragraph [0021] “determine a shape for the orthodontic alignment device based on ... plurality of forces applied to the teeth in combination with one or more forces applied to the palate…”; paragraph [0080] “modifying the size and/or shape of the PCA features”).
Sato et al. discloses the appliance can be “thermoform” (paragraph [0077]), but does not explicitly disclose that the shell and the palatal segment being polymeric. Hamm discloses an appliance specific to the patient, wherein polymers may be used to form the appliance (Fig. 1; paragraph [0006] “light-weight plastics or polymers are used”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Sato et al. by forming the appliance shell and palatal segment from polymeric material as taught by Hamm to be a suitable alternative material well known in the art for such dental appliances.
Regarding the newly recited limitations in claim 1 and the new claims 38-43:
Sato et al. discloses the appliance palatal segment 906 contacts the hard palate and exerts pressure to the hard palate to push out the anterior teeth (Fig.9A; paragraph [0065] “feature 906 is sized and shaped to conform to and exert pressure against the hard palate… pressure applied by the PCA feature 906 can be used to push out the anterior teeth”). Although implied, Sato et al. is not explicit that the appliance palatal segment 906 “applies corrective forces to expand at least one tooth of the upper jaw of the patient with a component in a forward direction during use, wherein the at least one tooth is selected from a central incisor, a lateral incisor, a canine, or a premolar of the upper jaw of the patient” and “move the hard palate upward or forward during use”, as claimed.
Hamm discloses an appliance specific to the patient, comprising a palatal segment 112 shaped to cover the hard palate (Fig. 1, paragraph [0033] “dental device 112 grippingly fits within upper palate 106 and upper plurality of teeth 108”); the palatal segment 112 contacts the hard palate and applies forces to the hard palate to adjust position of the hard palate of the upper jaw of the patient during use, that the segment 112 is configured to move the hard palate and the upper front teeth 116 (including the incisors) upward and/or forward (See Hamm Fig. 1, arrows A and V; abstract “provide anterior movement… and vertical movement to an anterior dental structure”; paragraph [0034] “Upper front palate 114 and upper front teeth 116 experience anterior movement and pressure applied by dental device 112, shown with arrow labeled A… [and] also vertical movement… shown with arrow labeled V”; )
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Sato et al. by configuring the palatal segment so as to adjust position and expand the hard palate and the upper front teeth forward and upward as taught by Hamm in order to provide efficient and effective orthodontic correction to appropriate teeth as applicable to orthodontic treatments customized to a patient’s needs and diagnoses.
Furthermore, as Sato/Hamm discloses expansion in a forward direction of the anterior teeth of the upper jaw, selecting a specific tooth from the anterior teeth (e.g. at least one tooth is selected from a central incisor, a lateral incisor, a canine, or a premolar) would have been obvious to one of ordinary skill in the art depending on required orthodontic treatment(s) customized to a patient’s needs and diagnoses.
As to claim 2, Sato et al. discloses the at least one appliance specific to the patient comprises a plurality of appliances specific to the patient which are used in a predefined order by the patient, wherein the plurality of appliances are configured to progressively adjust position of the teeth and hard palate of the upper jaw of the patient (paragraph [0005] “successive appliances in progressive configurations”; [0024] “a series of orthodontic alignment devices to sequentially move the teeth”).
As to claim 3, Sato et al.’s teaching of moving or stretching or otherwise transforming the isolated palate part of the three-dimensional model involves offsetting the palatal segment in the coordinate system, and modifying the size and/or shape of the palatal segment (see Sato et al.: Figs. 1A-1C; paragraph [0057] “offsets of the PCA feature 106 with respect to the palate in the X-axis, Y-axis, and/or Z-axis are used to control the location of the palatal surface contact areas”; Fig. 11, paragraphs [0078]-[0080] “modifying the size and/or shape of the PCA features…” ).. Such offsetting/moving and modification in size and shape are considered to include distortion or translation or rotation or other movement of the isolated palate part, as claimed.
Regarding claims 10, 12, and 44-47, Sato et al. in view of Hamm discloses the system including at least one appliance specific to the patient, as claimed, as detailed above with respect to claims 1, 3, and 38-43. Particularly, Sato discloses the geometry of the segment and the geometry of the shell for the appliance are derived from a three-dimensional model of the surfaces of the teeth and hard palate of the upper jaw of the patient (Sato et al. Fig. 11; paragraphs [0020-0021], [0078]-[0079]).
In claims 10 and 12, recitations “wherein the three-dimensional model is generated by: generating an initial three-dimensional model..” (claim 10 lines 13-26) and “moving or stretching or otherwise transforming the isolated palate part involves distortion or translation or rotation or other movement of the isolated palate part…” (claim 12) are product-by-process recitations in a product claim. Even though product-by-process recitation is limited by and defined by the recited process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). In this case, Sato et al. and Hamm discloses the end product and the structures thereof as claimed; thus the burden is shifted to applicant to show an unobvious difference.
As to claim 11, Sato et al. discloses the at least one appliance specific to the patient comprises a plurality of appliances specific to the patient which are used in a predefined order by the patient, wherein the plurality of appliances are configured to progressively adjust position of the teeth and hard palate of the upper jaw of the patient (paragraph [0005] “successive appliances in progressive configurations”; [0024] “a series of orthodontic alignment devices to sequentially move the teeth”).
As to claim 13, Sato et al. discloses the geometry of the shell 902/906 is configured such that the appliance expands the teeth of the upper jaw of the patient during use (see Sato et al. paragraph [0065] “push out the anterior teeth… distalize the posterior teeth”,
6. Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Sato et al. in view of Hamm, and further in view of Kopelman et al. (US 2016/0081768).
Sato/Hamm discloses the invention substantially as claimed as applied to claims 1 and 10, respectively, as detailed above. Per claims 4 and 14, although Sato/Hamm discloses the appliance can be “thermoform” (paragraph [0077]), which is a well known conventional process of forming such appliance by thermoforming a polymeric sheet over a physical model, Sato/Hamm fails to explicitly disclose the three-dimensional model is used to generate a physical model of the surfaces of the teeth and hard palate of the upper jaw of the patient; and the physical model is used as mold to form the particular appliance. Kopelman et al. discloses generating a physical dental model using the three-dimensional model, and the physical model is used as mold to form the particular appliance (see Kopelman paragraph [0067]-[0068] “The dental appliance can be made, for example, by thermoforming a piece of plastic over a physical dental model… The dental model… can be created from a virtual model”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Sato/Hamm by generating a physical model based on the three-dimensional model, and the physical model is used as mold to form the particular appliance as taught by Kopelman et al. for an efficient and effective orthodontic treatment.
Double Patenting
9. 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
10. Claims 1-4, 10-14, and 38-47, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 as unpatentable over Patent No. 11,478,336 in view of Sato et al. (US 2019/0021817) in view of Hamm (US 2021/0007831).
The application claims correspond to the patent claims as follows:
Application
Patent ‘336
1, 10, 13, 38-47
1
Application claims recite additional limitations which the patent claim lacks. However, such additional limitations would have been obvious in view of Sato and Hamm.
2, 11
2
Application and patent claims are essentially the same in scope.
3, 12
4
Application and patent claims are essentially the same in scope.
4, 14
3
Application and patent claims are essentially the same in scope.
Although the claims at issue are not identical, they are not patentably distinct from each other. Application claims 1, 10, 13, 38-47, recite the following additional limitations which are missing from patent claim 1:
"applies corrective forces to expand at least one tooth of the upper jaw of the patient with a component in a forward direction during use, wherein the at least one tooth is selected from a central incisor, a lateral incisor, a canine, or a premolar of the upper jaw of the patient" (application claim 1, 10, 13, 38-47);
"the at least one appliance contacts the hard palate and applies forces to the hard palate" (application claims 1, 10); and
"i) generating an initial three-dimensional model representing surfaces of the teeth and a hard palate of the upper jaw of the patient" (application claims 1, 10).
Nonetheless, Sato/Hamm discloses the above additional limitations as detailed above in the 35 U.S.C. 103 ground(s) of rejection of claims 1, 10, 13, 38-47. It would have been obvious to incorporate these limitations into patent claim 1 in order to achieve an optimum appliance providing efficient and effective orthodontic correction to appropriate anterior teeth depending on prescribed orthodontic treatments customized to a patient’s needs and diagnoses.
Application claim 1 recites "upward or forward during use.” (at the end of claim 1), which is broader than (a genus of) patent claim 1’s recitation “upward and forward during use". Application claim 3 includes additional language “distortion or”, which broaden the scope of the claim. broaden the scope of the claims. The corresponding recitations in the patent claims 1 and 4 include a narrower scope (species) and therefore anticipate corresponding application claims 1 and 3.
Response to Arguments
11. Applicant's arguments filed on 06/19/2026 have been fully considered but they are not persuasive.
Applicant argues that Sato et al. discloses distalizing force, not forward force; and Hamm does not disclose a polymeric shell. Such piecemeal arguments against the references individually are not persuasive. Note that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant further argues that the prior arts do not disclose the newly added limitations in the amended claims. Regarding the newly recited limitations in claim 1 and the new claims 38-43, it is maintained that Sato in view of Hamm discloses the invention as detailed in the above ground(s) of rejection. Applicant’s remarks are held to be responded to in the above ground(s) of rejection.
Conclusion
12. 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 Examiner HAO D. MAI whose telephone number is (571)270-3002. The examiner can normally be reached on Mon-Fri 8:00-4:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached on (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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/Hao D Mai/
Examiner, Art Unit 3772
/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772
