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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/10/2026 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application(s), Application No(s). 14466734, 15645690, 16384692, and 17861143 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more originally filed claims of this application.
Claim 4: The limitation, “the attachment structure…is fabricated via rapid prototyping” is not supported by the prior filed disclosures.
The prior filed applications only disclose using rapid prototyping to provide modified physical models of the patient’s jaws, and direct fabrication of a physical appliance, but there is not support for rapid prototyping of the attachment structure (14466734, page 10, lines 16-19, page 11, lines 14-19; 15645690, page 13, paragraph 4, page 14, paragraph 4; 16384692 and 17861143, Paragraphs [0050], [0054])
Applicant has support for the first and second appliances being formed by rapid prototyping as Examiner is interpreting “rapid prototyping” as “direct fabrication”. Examiner further recommends Applicant amend claim 4 to exclude “the attachment structure” and include “direct fabrication”.
Claim 5: The limitation, “the attachment structure…is fabricated via thermoforming”, is not supported by the prior filed disclosures. The prior filed applications disclose fabricating appliances by thermoforming; however, there is not support for thermoforming the attachment structure (14466734, page 10, lines 16-19, page 11, lines 14-19; 15645690, page 13, paragraph 4, page 14, paragraph 4; 16384692 and 17861143, Paragraphs [0050], [0054]).
As Applicant has support for the first and second appliances being formed by thermoforming, Examiner recommends Applicant amend the claim 5 language to exclude “the attachment structure”.
For the purpose of examination, the priority date for claims 4-5 is 07/18/2023. The priority date for claims 1-3, 6-15, 17-20, and 22 is 08/22/2014.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claim 4: The limitation, “one or more of the attachment structure, the first appliance, and the second appliance is fabricated via rapid prototyping”, is not supported by the disclosure. Paragraph [0050] only discloses using rapid prototyping to provide modified physical models of the patient’s jaws, with Paragraph [0054] further disclosing direct fabrication of a physical appliance, but there is not support for rapid prototyping of the appliances and/or attachment structure.
Claim 5: The limitation, “the attachment structure…is fabricated via thermoforming”, is not supported by the disclosure. Paragraph [0050] discloses fabricating appliances by thermoforming; however, there is not support for thermoforming the attachment structure.
It is noted that each of the claims were originally filed with the current application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15, 17-20, and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 introduces new matter into the claim as follows:
The limitations, “a first set of attachments and second set of attachments”, (line 5) are not are not supported by the original disclosure. The plurality of attachments separated by spaces are supported by Fig. 2B, which shows a plurality of attachment structure components (Paragraph [0066]); however, there is not language to support which of these plurality of attachments are a first or second set of attachments.
The limitation, “a first set of walls that are out of alignment with respect to the first set of attachments”, (line 8) is not supported by the original disclosure. The disclosure describes a cavity being out of alignment with a current tooth configuration and shaped to interface with a first surface or a first subset of the plurality of surfaces of the attachment structure, also called active surfaces (Paragraphs [0031], [0033], [0035], [0037], [0087], [0107]), but there is not language to support “walls” as being out of alignment with a set of attachments.
The limitation, “a second cavity includes a second set of walls that are out of alignment with respect to the second set of attachments”, (lines 15-16) is not supported by the original disclosure. Similar to the limitation above for the first set of walls, the disclosure describes a cavity being out of alignment with a current tooth configuration and shaped to interface with a second surface or a second subset of the plurality of surfaces of the attachment structure, also called active surfaces (Paragraphs [0031], [0033], [0035], [0039], [0087], [0107]), but there is not language to support “walls” as being out of alignment with a set of attachments.
Further, the limitation, “the second set of walls is in alignment with the first set of attachments,” (lines 19-20) is also not supported by the disclosure for the same reasons as described above; there is not language supporting separate first and second set of attachments, and there is not language to support a set of walls in alignment with the first set of attachments.
The limitation, “wherein the second set of attachments is different than the first set of attachments”, (lines 21-22) is not supported by the original disclosure, as Paragraph [0042] only provides support for a first subset and second subset of surfaces with at least one surface that is different between them.
Claim 14 introduces new matter into the claim as follows:
The limitations, “a first set of at least two attachments and second set of at least two attachments”, (lines 5-6) are not are not supported by the original disclosure. The plurality of attachments separated by spaces are supported by Fig. 2B, which shows a plurality of attachment structure components (Paragraph [0066]); however, there is not language to support which of these plurality of attachments are a first or second set of attachments.
The limitation, “the first shell configured to simultaneously engage with the first set of at least two attachments”, (lines 8-9) is not supported by the original disclosure. The disclosure only describes a cavity being out of alignment with a current tooth configuration and shaped to interface with a first surface or a first subset of the plurality of surfaces of the attachment structure, also called active surfaces (Paragraphs [0031], [0033], [0035], [0037], [0087], [0107]).
The limitation, “at least two attachments of the first set of at least two attachments are separated,” (lines 11-12) is also not supported by the original disclosure for the same reasons as described above; there is not language supporting a first set of attachments, although separate attachment components are disclosed with a space between them (Paragraph [0066], Fig.2B) .
The limitation, “the second shell configured to simultaneously engage with the second set of at least two attachments”, (lines 15-16) is not supported by the original disclosure. Similar to the limitation above for the first shell, the disclosure only describes a cavity being out of alignment with a current tooth configuration and shaped to interface with a second surface or a second subset of the plurality of surfaces of the attachment structure, also called active surfaces (Paragraphs [0031], [0033], [0035], [0039], [0087], [0107]).
The limitation, “at least two attachments of the second set of at least two attachments are separated,” (lines 18-19) is also not supported by the original disclosure for the same reasons as described above; there is not language supporting a second set of attachments, although separate attachment components are disclosed with a space between them (Paragraph [0066], Fig.2B).
The limitation, “wherein the second set of at least two attachments is different than the first set of at least two attachments”, (lines 21-22) is not supported by the original disclosure, as Fig.2B only shows three attachments. If the two sets of attachments each have two attachments at minimum, and no attachment belongs to both sets, there must be at least four attachments.
Claim 20 introduces new matter into the claim as follows:
The limitations, “a first set of attachments and second set of attachments”, (lines 5-6) are not are not supported by the original disclosure. The plurality of attachments separated by spaces are supported by Fig. 2B, which shows a plurality of attachment structure components (Paragraph [0066]); however, there is not language to support which of these plurality of attachments are a first or second set of attachments.
The limitation of, “a first cavity of the plurality of first cavities is shaped to engage with the first set of attachments”, (lines 8-10) is not supported by the original disclosure. The disclosure only describes a cavity being out of alignment with a current tooth configuration and shaped to interface with a first surface or a first subset of the plurality of surfaces of the attachment structure, also called active surfaces (Paragraphs [0031], [0033], [0035], [0037], [0087], [0107]), but not a set of attachments.
The limitation of, “a second cavity of the plurality of second cavities is shaped to engage with the second set of attachments”, (lines 14-16) is not supported by the original disclosure. The disclosure only describes a cavity being out of alignment with a current tooth configuration and shaped to interface with a second surface or a second subset of the plurality of surfaces of the attachment structure, also called active surfaces (Paragraphs [0031], [0033], [0035], [0039], [0087], [0107]), but not a set of attachments.
Claims 2-15, 17-20, and 22 are rejected under 112(a), as they contain all the deficiencies of the claims from which they depend.
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 1-15, 17-20, and 22 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, “an attachment structure…including a plurality of discrete attachments…wherein the plurality of discrete attachments includes a first set of attachments and a second set of attachments”. These limitations are unclear as to whether a single attachment structure is being claimed (Fig. 2A), or a plurality of discrete attachments (Fig. 2B). Thus, the remainder of the claim is also unclear as to what structure the appliances are configured to engage.
For examination purposes, Examiner is interpreting claim 1 as stating there are a plurality of discrete attachment structure components, where each attachment structure component of the plurality of attachment structure components has a plurality of surfaces (Paragraphs [0066]-[0067], Fig. 2B). Thus each of the discrete attachment structure components includes a first set of surfaces and second set of surfaces among the plurality of surfaces (Paragraphs [0037], [0039], Fig. 2B). Further, the first aligner is configured to interface with only the first subset of the plurality of surfaces to apply a first engagement force (Paragraph [0037]), and the second aligner is configured to interface with only the second subset of the plurality of surfaces to apply a second engagement force (Paragraph [0039]).
Claim 14 recites, “an attachment structure…including a plurality of discrete attachments…wherein the plurality of discrete attachments includes a first set of at least two attachments and a second set of at least two attachments…wherein the second set of at least two attachments is different than the first set of at least two attachments”. These limitations are unclear as to whether a single attachment structure is being claimed (Fig. 2A), or at least two sets of two discrete attachments are being claimed. Thus, the remainder of the claim is also unclear as to what structure the first and second shells are configured to engage.
For examination purposes, Examiner is interpreting claim 14 as stating there are a plurality of discrete attachment structure components, where each attachment structure component of the plurality of attachment structure components has a plurality of surfaces (Paragraphs [0066]-[0067], Fig. 2B). Thus each of the discrete attachment structure components includes a first set of at least two surfaces and second set of at least two surfaces among the plurality of surfaces (Paragraphs [0037], [0039], Fig. 2B). Further, the first shell is configured to interface with only the first subset of the at least two surfaces to apply a first engagement force (Paragraph [0037]), and the second shell is configured to interface with only the second subset of the at least two surfaces to apply a second engagement force (Paragraph [0039]).
Claim 20 recites, “an attachment structure…including a plurality of discrete attachments…wherein the plurality of discrete attachments includes a first set of attachments and a second set of attachments”. These limitations are unclear as to whether a single attachment structure is being claimed (Fig. 2A), or a plurality of discrete attachments (Fig. 2B). Thus, the remainder of the claim is also unclear as to what structure the appliances are configured to engage.
For examination purposes, Examiner is interpreting claim 20 as stating there are a plurality of discrete attachment structure components, where each attachment structure component of the plurality of attachment structure components has a plurality of surfaces (Paragraphs [0066]-[0067], Fig. 2B). Thus, each of the discrete attachment structure components includes a first set of surfaces and second set of surfaces among the plurality of surfaces (Paragraphs [0037], [0039], Fig. 2B). Further, the first shell is configured to interface with only the first subset of the plurality of surfaces to apply a first engagement force (Paragraph [0037]), and the second shell is configured to interface with only the second subset of the plurality of surfaces to apply a second engagement force (Paragraph [0039]).
Based on the interpretation of independent claims 1, 14 and 20:
The limitation, “the plurality of surfaces”, in claims 6-9, and 17-18 does not raise the issue of insufficient antecedent basis.
The limitation, "the first subset of surfaces" and “the second subset of surfaces”, in lines 1-2 of claim 13 does not raise the issue of insufficient antecedent basis.
The limitation, "the at least two first surfaces" and “the at least two second surfaces”, in lines 2-4 of claims 15 and 19 does not raise the issue of insufficient antecedent basis.
Examiner notes the antecedent basis of the above limitations, as it is only under the described interpretation of claims 1, 14 and 20, that the issue of insufficient antecedent basis is not raised as part of the 35 U.S.C. 112(b) rejection(s).
Claims 2-15, 17-20, and 22 are rejected under 112(b), as they contain all the deficiencies of the claims from which they depend.
Allowable Subject Matter
Claims 1, 14 and 20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The closest prior art of record includes the following:
Martz (US 4793803 A) discloses a plurality of discrete attachments (101, 102, 103) that project outward and are separated from each other by one or more spaces (refer to Fig. 23a), with a plurality of surfaces formed by vertical grooves (96e) (refer to annotated Fig. 23 below), where the appliance is configured to interface with the attachments (101, 102, 103) (refer to col. 5, lines 15-20, 55-58; buttons are bonded onto the teeth to facilitate the clasp portions of the appliance gripping the teeth more effectively); however, Martz does not disclose a first appliance or shell configured to interface with only the first subset of the plurality of surfaces (or at least two surfaces) to apply a first engagement force and a second shell or appliance configured to interface with only the second subset of the plurality of surfaces (or at least two surfaces) to apply a second engagement force.
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Knopp et al. (US 20040229183 A1) discloses two attachments (301) separated by a space; however, these attachments (301) are not discrete, as they share a common base (102) (refer to Paragraph [0059], Fig. 9K).
Phan et al. (US 6299440 B1) discloses a plurality of discrete attachments (500) that project outward and are separated from each other by one or more spaces (refer to Fig. 14D), with an appliance (501) configured to interface with the attachments (500) (refer to col. 8, lines 47-50, 55-60, Fig. 14D); however, Phan et al. does not disclose a first appliance or shell configured to interface with only the first subset of the plurality of surfaces (or at least two surfaces) to apply a first engagement force and a second shell or appliance configured to interface with only the second subset of the plurality of surfaces (or at least two surfaces) to apply a second engagement force.
Response to Arguments
The outstanding 35 U.S.C. 112(a) rejection of claim 20 is withdrawn in view of the newly submitted claim amendment.
Applicant’s arguments with respect to claim(s) 1-15, and 17-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The current rejection relies on the series of 35 U.S.C. 112(b) rejections as highlighted above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adriena J Webb Lyttle whose telephone number is (571)270-7639. The examiner can normally be reached Mon - Fri 10:00-7:00 EST.
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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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/ADRIENA J WEBB LYTTLE/Examiner, Art Unit 3772
/HEIDI M EIDE/Primary Examiner, Art Unit 3772
6/1/2026
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