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 .
Drawings
The drawings were received on 09/03/2025. These drawings are unacceptable as they still have reference numeral “2” being used to designate both a portion of an aligner having flat occlusal surface and a portion of an aligner having the “shape of teeth”
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
-reference character “1” has been used to designate both an aligner having a flat surface and also an aligner not having a flat surface in in figs. 1 and 2.
- reference character “3” has been used to designate both an occlusal surface and a canine region ramp in figured 2.
- reference character “2” has been used to designate both a portion of an aligner having flat occlusal surface and a portion of an aligner having the “shape of teeth” in figured 2.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Response to Arguments
Applicant's arguments filed 09/03/2025 have been fully considered but they are not persuasive. Applicant has argued that Weile et al. (US 2021/0353451) fails to provide for a dual-side configuration, however this is not persuasive as Weile does provide the first and second sides that have the claimed flat surface and “tooth shaped surface” respectively. The term “tooth shaped surface” is a broad term that Weile’s molded surfaces do provide for.
Applicant has argued that Weile fails to provide for opposing flat and tooth shaped surfaces, however the surfaces of Weile are opposed in their positioning when worn.
Applicant has argued that Weile does not provide for the claimed laterality and anterior guidance movements, however this is not persuasive as when the guides o Weile are on the patient, in order for them to occlude their jaws the guides would provide the guidance movement laterally and anteriorly by their interaction.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., smooth movements which disoccluding posterior teeth, excursions, etc.) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant has further argued that claim 1 requires both arches include flat surfaces, however this is narrower than the current claim language, which only requires that there is one flat surface in the upper and lower arches.
In response to applicant's argument that the prior art of Weile can be used to treat other conditions and applicant intends for the mandible to be moved during use, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The new prior art of Hung et al. has been cited for claims 1 and various new claims.
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 5-9 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 5 recites the limitation of “configured to provide muscle relaxation”, however this renders the claim unclear as providing muscle relaxation depends on some unknown patient’s particular anatomical arrangement and thus would link the configuration to an indefinite anatomical arrangement of a patient which is not part of the invention. For purposes of examination any prior art that provides for structure which would be capable of moving some possible patient’s teeth with any of inclination, proclination, or lingualization will be deemed to provide for the claimed limitation.
The term “feels comfort and relief of muscle symptoms” in claim 5 is a relative term which renders the claim indefinite. The term “comfort” and “relief” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The configuration which would provide for the subjective comfort or relief is rendered indefinite and unclear. For purposes of examination any prior art that provides structure that would allow for moving teeth in inclination, proclination, or lingualization will be deemed to provide for the claim limitations.
Claim 6 recites the limitation of contacts of antagonistic teeth are made with tip of cusp of the flat surface, however claim 1 discloses that the aligner has both an upper arch and a lower arch and thus the actual cusp of teeth could not contact the flat surfaces as they would be inside either the upper or lower arch. For purposes of examination any prior art where one of the upper or lower arch alone would contact teeth cusp tips will be deemed to provide for the claim limitation.
Claim 7 recites the limitation "the contact of the tip of cusp" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 further recites the limitation of where the contact of the tip of cusp of the flat surface, however claim 1 discloses that the aligner has both an upper arch and a lower arch and thus the actual cusp of teeth could not contact the flat surfaces as they would be inside either the upper or lower arch. For purposes of examination any prior art where one of the upper or lower arch alone would contact teeth cusp tips will be deemed to provide for the claim limitation.
Claim 7 recites the limitation of “wherein the contact of the tip of cusp on the flat surface causes dememorization”, however this renders the claim indefinite as depending on some unknown arrangement that would affect some undefined patient’s specific anatomy. For purposes of examination any prior art which could have cusp tips contact flat surfaces will be deemed to provide for such limitations.
Claim 7 further recites the term “causing muscle relaxation” which renders the claim indefinite. The term “relaxation” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The configuration which would provide for the subjectively perceived effect of relaxation is rendered indefinite and unclear. For purposes of examination any prior art that provides structure that would allow for moving teeth will be deemed to provide for the claim limitations.
Claims 8 and 9 recite the limitation of “wherein when the flat surface is in an upper (claim 8)/lower(claim 9) arch” contact occur with cusp tips of the opposite arch, however this renders the claims unclear as claim 1 recites the aligner includes an upper and lower arch and thus no cusps of teeth themselves will be able to be contacted. For purposes of examination any prior art that provides for contacts when only on of an upper or lower arch aligner is worn will be deemed to provide for the claim limitations.
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 1-2, 5, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wiele et al. (US 2021/0353451 A1).
Regarding claims 1 and 10, Wiele discloses providing an orthodontic aligner (title and abstract) having an aligner (Fig. 7a/8a element 110/114) with one side that is flat (Fig. 7a/8a element 120/123) and the second side opposite the first side comprises an arch that has a shape of teeth (Fig. 7a element showing the surface of 16 having the shape of teeth 144, further Fig. 8a element 170 is tooth shaped, Fig. 8a elements 160 being tooth shaped which is a broad term), in which there is a ramp in a canine region, canine, guide, to direct laterality and anterior guidance movements when possible (Fig. 7a/8a element 112/132/136, paragraph [0071] lines 1-3 disclosing “cuspid guidance (canine lateral or anterior guidance)”), wherein in both an upper arch and a lower arch of the aligner, a flat surface forms an occlusal surface that includes canine guidance in the canine region (Fig. 7c elements 123/160).
Regarding claim 2, Wiele further discloses wherein each occlusal surface of the upper and lower arches is flat (Fig. 7c elements 160 and 123 are flat) and wherein the occlusal surface in the canine region includes a canine guide and anterior guide (Fig. 7a occlusal feature elements 152 and 116 provide canine and anterior guidance).
Regarding claim 5, Wiele further discloses where the orthodontic aligner is configured to move teeth with inclination, proclination, or lingualization with would for a patient provide a feeling of comfort and relief (paragraph [0023] lines 31-33 disclosing patients could have overbites which is a proclination, further the appliances are configured to move teeth by their guides and are formed from patients teeth, thus should a patient have inclined teeth, proclined teeth, or lingualized teeth the would be moved the guides moving the jaws).
Claims 1, 5-8, 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hung et al. (US 2016/0310237 A1).
Regarding claims 1 and 10, Hung discloses providing an orthodontic aligner (title and abstract) having an aligner (Fig. 1 element 1) with one side that is flat (Fig. 1 element 100 having planer/flat surfaces) and the second side opposite the first side comprises an arch that has a shape of teeth (Fig. 4 element 200 having occlusal surface that have the same of teeth), in which there is a ramp in a canine region, canine, guide, to direct laterality and anterior guidance movements when possible (Fig. 4 element 110a), wherein in both an upper arch and a lower arch of the aligner, the flat surface of the first side forms an occlusal surface that includes canine guidance in the canine region (Fig. 2a plane P1 forms the occlusal surface that includes the canine guidance area at canine 12c ).
Regarding claim 5, Hung further discloses where the orthodontic aligner is configured to move teeth with inclination, proclination, or lingualization with would for a patient provide a feeling of comfort and relief (Fig. 2b showing the moving of a tooth with improper inclination).
Regarding claim 6, Hung further discloses wherein contacts with antagonistic teeth would be made with a tip cusp on the flat surface (Fig. 2a showing protrusions/tips P2 contacting planer/flat P1).
Regarding claim 7, Hung discloses where the contact of the tip of cusp on a flat surface causes a dememorization of occlusal contacts causing muscle relaxation (Fig. 2a element 100a, paragraph [0026] disclosing the limiting parts would guide the lower jaw and limiting movement during mastication which would dememorize the muscle when worn which would cause come muscle relaxation)
Regarding claim 8, Hung further discloses where the flat surface is on the upper arch and contact occur with a buccal cusp tip of the lower arch (Fig. 2a showing the plane/flat surface on the upper arch and the contact would be with the occlusal buccal side of the lower arch).
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.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Wiele et al. (US 2021/0353451 A1).
Regarding claims 3 and 4, Weile discloses the claimed invention except for the material of the aligner being acetate or polyurethane. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have chosen the material of Weile to be either acetate or polyurethane as Weile discloses the aligner can be any orthodontic acrylic or other suitable material (paragraph [0104] all), since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 3, 4, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hung et al. (US 2016/0310237 A1).
Regarding claims 3 and 4, Hung discloses the claimed invention except for the material of the aligner being acetate or polyurethane. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have chosen the material of Hung to be either acetate or polyurethane as Hung discloses the aligner can be any orthodontic resin or other suitable material for use in oral appliances (paragraph [0040] all), since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 9, Hung discloses the claimed invention except for the flat surface being on the lower arch and the occlusal contact being on the lingual cusp instead of being on the upper arch and the buccal cusp, However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have reversed the location of the flat surface and the guide from the upper to the lower aligner and from the buccal outer cusp to the lingual inner cusp, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
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, Eric Rosen can be reached at (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.P.S/Examiner, Art Unit 3772
/THOMAS C BARRETT/SPE, Art Unit 3799