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 .
REQUIREMENT FOR UNITY OF INVENTION
2. As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
3. This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
Species I: Figs. 2-9, claims 1-4 and 10-14, drawn to method and system for repositioning upper teeth and palate.
Species II: Figs. 10-16, claims 5-9, 15-29, and 34-37, drawn to method and system for repositioning lower teeth and mandibular bone.
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, claims 1 and 10 are generic.
4. Groups I-II lack unity of invention because:
Group I is directed to the technical feature of repositioning upper teeth and palate (see Figs. 2-9, claims 1-4 and 10-14).
Group II is directed to the technical feature of repositioning lower teeth and mandibular bone (see Figs. 10-16, claims 5-9, 15-19, 20-29, and 34-37).
Therefore, Groups I-II define different technical features. It is noted that the dependent claims 5-9, 15-19, and 34-37 (of Group II) depend on claims 1 and 10 (of Group I), and therefore link Groups I and II to share common subject matters being orthodontic appliances for either the upper jaw or the lower jaw. Furthermore, the claimed upper and lower appliances can be used together, presenting corresponding technical features. However, such shared common and/or corresponding technical features are NOT special technical features since they do not make a contribution over the prior art in view of Kopelman et al. (2016/0081768).
Kopelman et al. discloses at least one appliance 100 specific to the patient for placement in the patient's mouth during use, wherein the at least one appliance 100 comprises a polymeric shell 102 having a cavity shaped to receive teeth of the upper jaw or lower jaw, and a polymeric segment 104/106 configured to contact either the palate or the mandibular bone portion (see Kopelman et al. Fig. 1, paragraph [0039] “An appliance having a cavity shaped to receive… teeth present in the upper and/or lower jaw”; paragraphs [0041]-[0042] “appliance 100 can include an arch element… expand across.. a palate and/or floor of the mouth”).
Accordingly, Groups I-II lack unity of invention.
5. During a telephone conversation with Attorney Jay Sbrollini on 11/10/2025 a provisional election was made to prosecute the species of Group I, directed to Figs. 2-9, claims 1-4 and 10-14.
Affirmation of this election (and indication whether the election is made with or without traverse) must be made by applicant in replying to this Office action.
Claims 5-9, 15-29 and 34-37 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
6. Status of the claims:
Claims 1-29 and 34-37 are pending. Claims 30-33 have been cancelled.
Claims 1-4 and 10-14, directed to the Species of Group I, are provisionally elected to be examined for patentability; claims 1-4 and 10-14 are examined as detailed herein below.
Claims 5-9, 15-29, and 34-37, directed to the Species of Group II, are withdrawn.
Double Patenting
7. 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.
8. Claims 1-4 and 10-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 10-12 of U.S. Patent No. 11,478,336 (reference patent) in view of Kopelman et al. (US 2016/0081768).
Refer to the table below for comparison mapping of the instant application claims 1-4 and the reference patent claims 1-4 and 10-12. The markings show the differences between the claims: italicizing shows similarities, bolding shows differences, underlining shows additional limitations in the instant application claims.
Instant Application
US Patent 11,478,336
1. A method for repositioning teeth of a patient, comprising:
providing at least one appliance specific to the patient for placement in the patient's mouth during use, wherein the at least one appliance comprises a polymeric shell having a cavity shaped to receive teeth of the upper jaw of the patient, the polymeric shell integral to a polymeric segment shaped to cover the hard palate of the upper jaw of the patient;
wherein geometry of the shell is configured such that the at least one appliance adjusts position of the teeth of the upper jaw of the patient during use, and wherein geometry of the segment 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;
wherein the geometry of the segment and the geometry of the shell for a particular appliance are derived from a three-dimensional model of the surfaces of the teeth and hard palate of the upper jaw of the patient; 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,
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,
iii) moving the isolated tooth part of the initial three-dimensional 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, 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.
1. A method for repositioning teeth of a patient, comprising:
providing at least one appliance specific to the patient for placement in the patient's mouth during use, wherein the at least one appliance comprises a polymeric shell having a cavity shaped to receive teeth of the upper jaw of the patient, the polymeric shell integral to a polymeric segment shaped to cover the hard palate of the upper jaw of the patient;
wherein geometry of the shell is configured such that the at least one appliance adjusts position of the teeth of the upper jaw of the patient during use, and wherein geometry of the segment is configured such that the at least one appliance adjusts position of the hard palate of the upper jaw of the patient during use;
wherein the geometry of the segment and the geometry of the shell for a particular appliance are derived from a three-dimensional model of surfaces of the teeth and hard palate of the upper jaw of the patient; 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) isolating a tooth part of a three-dimensional model which corresponds to surfaces of at least one tooth of the upper jaw of the patient,
ii) moving the isolated tooth part of the three-dimensional model such that the shell of the particular appliance is configured to expand the teeth of the upper jaw of the patient during use,
iii) isolating a palate part of a three-dimensional model which corresponds to surfaces of the hard palate of the upper jaw of the patient, and
iv) moving, stretching, or otherwise transforming the isolated palate part of the
three-dimensional model such that the geometry of the segment of the particular appliance is configured to move the hard palate upward and forward during use.
2. A method according to claim 1, wherein: 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.
2. A method according to claim 1, wherein: 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.
3. A method according to claim 1, wherein: the moving or stretching or otherwise transforming the isolated palate part involves distortion or translation or rotation or other movement of the isolated palate part relative to a reference coordinate system defined in the initial three-dimensional model.
4. A method according to claim 1, wherein: the moving, stretching, or otherwise transforming the isolated palate part of the three-dimensional model involves translation or rotation or other movement of the isolated palate part of the three-dimensional model relative to a reference coordinate system defined in the three-dimensional model.
4. A method according to claim 1, wherein: 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.
3. A method according to claim 1, wherein: the three-dimensional model is used to generate a physical model of the upper jaw of the patient; and the physical model is used as a mold to form a particular appliance.
10. A system for repositioning teeth of a patient, comprising:
at least one appliance specific to the patient for placement in the patient's mouth during use, wherein the at least one appliance comprises a polymeric shell having a cavity shaped to receive teeth of the upper jaw of the patient, the polymeric shell integral to a polymeric segment shaped to cover the hard palate of the upper jaw of the patient, wherein geometry of the shell is configured such that the appliance adjusts position of the teeth of the upper jaw of the patient during use, and wherein geometry of the segment is configured such that the 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;
wherein the geometry of the segment and the geometry of the shell for a particular appliance are derived from a three-dimensional model of the surfaces of the teeth and hard palate of the upper jaw of the patient; 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;
ii) isolating a tooth part of the initial [[a]] three-dimensional model which corresponds to surfaces of at least one tooth of the upper jaw of the patient,
iii) moving the isolated tooth part of the initial three-dimensional 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, 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.
11. A system according to claim 10, wherein: 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.
12. A system according to claim 10, wherein: the moving or stretching or otherwise transforming the isolated palate part involves distortion or translation or rotation or other movement of the isolated palate part relative to a reference coordinate system defined in the initial three-dimensional model.
13. A system according to claim 10, wherein: the geometry of the shell is configured such that the appliance expands the teeth of the upper jaw of the patient during use.
14. A system according to claim 10, wherein: 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.
10. A system for repositioning teeth of a patient, comprising:
at least one appliance specific to the patient for placement in the patient's mouth during use, wherein the at least one appliance comprises a polymeric shell having a cavity shaped to receive teeth of the upper jaw of the patient, the polymeric shell integral to a polymeric segment shaped to cover the hard palate of the upper jaw of the patient, wherein geometry of the shell is configured such that the at least one appliance adjusts position of the teeth of the upper jaw of the patient during use, and wherein geometry of the segment is configured such that the at least one appliance adjusts position of the hard palate of the upper jaw of the patient during use; and…
at least one additional appliance specific to the patient for placement in the patient's mouth during use, wherein the at least one additional appliance comprises a polymeric shell having a cavity shaped to receive teeth of the lower jaw of the patient, wherein geometry of the shell is configured such that the at least one additional appliance adjusts position of the teeth of the lower jaw of the patient during use; wherein the at least one additional appliance includes a polymeric segment integral to the shell, wherein the segment is configured to contact a mandibular bone portion disposed below the gingiva of the teeth of the lower jaw, wherein geometry of the segment is configured such that the at least one additional appliance adjusts position of the mandibular bone portion of the lower jaw of the patient during use.
11. A system according to claim 10, wherein: the geometries of the shell and segment for a particular additional appliance is derived from a three-dimensional model of the surfaces of the teeth and mandibular bone portion of the lower jaw of the patient.
12. A system according to claim 10, wherein: the at least one additional appliance specific to the patient comprises a plurality of additional appliances specific to the patient which are used in a predefined order by the patient, wherein the plurality of additional appliances are configured to progressively adjust position of the teeth and mandibular bone portion of the lower jaw of the patient.
As shown in the table above, the application claims 1-4 corresponds to the reference patent claims 1-2, 4, and 3, respectively.
Although the patent claims do not recite the additional (underlined) limitations in the application claims, such additional limitations would have been obvious in view of Kopelman et al.
Regarding the additional limitations in the application claims 1-4, Kopelman et al. discloses a dental appliance 100 comprising shell 102 and palatal segment 104/106 that contacts the hard palate and applies forces to the hard palate (see Kopelman et al. Fig. 1, paragraphs [0047] “material 104 can be adjacent to and/or in contact with… the palate”; paragraph [0048] “expansion… include … stretching of the maxillary suture”).
Kopelman et al. further discloses 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 (Kopelman et al. paragraphs [0060]-[0062] “A virtual model… include an initial virtual dental model and/or an intermediate virtual dental 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 the patent claims to include the generating an initial model and intermediate models as taught by Kopelman et al. in order to reposition teeth in a sequential series of initial-intermediate-final stages as well known in the orthodontic field.
Note that the additional limitations “and/or” in application claim 1, and “distortion or” in application claim 3, broaden the scope of the claims. The corresponding reference patent claims 1 and 4 include a narrower scope and therefore anticipates the application claim 3.
The application claims 10-11 corresponds to the reference patent claims 10-12. The differences between the claims are the application claims recite “hard palate of the upper jaw” (application claims 10-11) while the patent claims recite “mandibular bone portion of the lower jaw” (patent claims 10-11). Nonetheless, Kopelman discloses appliance 100 including shell 102 having a cavity shaped to receive teeth of the upper jaw or lower jaw, and a arch segment 104/106 configured to contact either the palate or the mandibular bone portion (see Kopelman et al. Fig. 1, paragraph [0039] “An appliance having a cavity shaped to receive… teeth present in the upper and/or lower jaw”; paragraphs [0041]-[0042] “appliance 100 can include an arch element… expand across.. a palate and/or floor of the mouth”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the patent by configure the appliance to adapt to the teeth and hard palate of the upper jaw as disclosed by Kopelman et al. in order to effectively treat the upper jaw.
Application claims 10 and 12 recite additional limitations “wherein the three-dimensional model of the surfaces of the teeth and hard palate of the upper jaw of the patient is generated by…” (claim 10), and “the moving.. involves distortion…” (claim 12), which are product-by-process recitations in product claims. 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, the reference patent claims recite the end product and its structures; Kopelman et al. also discloses the end product and its structures as claimed; therefore the claims are met by the patent claims in view of Kopelman et al.
With regard to the application claims 13-14, Kopelman et al. disclose that the geometry of the shell is configured such that the appliance expands the teeth of the upper jaw of the patient during use (see Kopelman abstract) and that 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 (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 the patent claims by including such features of: the shell being configured to expands the teeth and the intended usage of the three-dimensional model to generate a physical model to form the appliance as taught by Kopelman et al. for an efficient and effective orthodontic treatment.
Claim Rejections - 35 USC § 112
9. 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.
10. Claims 1-4 and 10-14 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.
Claim 1 recites “a particular appliance” (lines 11-12) and “the particular appliance” (lines 26-27); claim 4 recites “the particular appliance” (line 4). Such recitations are indefinite because it is unclear whether such “particular appliance” is the same as, different from, or part of the previously defined antecedent basis “at least one appliance” (claim 1 line 2).
Similarly, claim 10 recites “a particular appliance” (lines 10-11) and “the particular appliance” (lines 25- 26); claim 14 recites “the particular appliance” (line 4). Such recitations are indefinite because it is unclear whether such “particular appliance” is the same as, different from, or part of the previously defined antecedent basis “at least one appliance” (claim 10 line 2).
Claim 10 recites “the appliance” (line 6), and claim 13 recites “the appliance” (line 2), which lack antecedent basis. It is unclear whether such “the appliance” is the same as, different from, or part of the previously defined antecedent basis “at least one appliance” (claim 10 line 2).
All dependent claims are rejected herein based on dependency.
Claim Rejections - 35 USC § 103
11. 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.
12. Claims 1-3 and 10-13 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 the 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 a particular 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.
Sato et al. discloses the appliance palatal segment 906 contacts the hard palate and applies forces 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 such pushing out the anterior teeth implies pushing out of the palate underneath the anterior teeth, Sato et al. is not explicit that the appliance palatal segment 906 “adjust position of the hard palate of the upper” and “move the hard palate upward and/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 upward and/or forward (See Hamm Fig. 1; abstract “provide anterior movement… and vertical movement to an anterior dental structure”; paragraph [0034] “Upper front palate 114 … 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 of the hard palate by moving the hard palate upward and/or forward as taught by Hamm in order to provide efficient and effective orthodontic correction to the anterior dental structure.
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 and 12, 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 and 3. 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”,
13. 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.
Conclusion
14. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. 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