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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/05/2026 has been entered.
Response to Arguments
Applicant's arguments filed 05/05/2026 have been fully considered but they are not persuasive.
Applicant has argued that Kuo fails to provide for the new claim limitations of “the interface surface of the tissue shaping feature…has a shape that matches a shape of an expected tooth implant”, however upon further search and consideration Kuo is found to provide for such a limitation as cited in the following action. The designing of the appliances and the tissue shaping feature cited in Kuo are done using virtual dental models including virtual crowns to be placed and thus would be tooth implants that would be expected to be placed.
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 1-3, 5-8, 10-14, 16-24 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. Independent claims 1 and 11 both recite the new limitation of “wherein an interface surface of the tissue shaping feature, that is configured to contact the gingiva interface region of the patient’s gingiva, has a shape that matches a shape of an expected tooth implant.” and claim 22 reciting “the shape of the interface surface…has a shape that matches a shape of a portion of a crown of an extracted tooth”, and claim 23 reciting “the shape of the interface surface…matches a shape of an interface surface of a three dimensional tooth model of the extracted tooth”, none of which is supported by the original disclosure. The original disclosure only provides support for the interface “surface” feature itself to “correspond” to an implant interface surface in paragraph [0077] “the tissue shaping feature model may include a surface that correspond to at least an implant interface surface (e.g., 121) of an expected tooth implant” but does not recite an interface surface that matches an expected tooth implant.
Paragraph [0077] discloses that “the tooth shaping feature may have a crown shape that matches the crown shape of the expected tooth implant” which only provides for the broader element of the “tooth shaping feature” to have a “crown shape” that would match the “crown shape of the expected tooth implant”, while the “an interface surface” would be a subpart of the “tooth shaping feature” that is not disclosed as having a shape that matches a crown of an expected tooth implant. The only disclosure of any matching of the extracted tooth by the tissue shaping feature is in relation to matching color not shape. The only disclosure of the “interface surface” in relation to a 3D model is in paragraph [0047] which recites a corresponding shape and not a matching shape.
As such the claims recite new matter.
Any claim depending upon a claim reciting new matter also recite new matter.
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 20-24 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.
Claims 20 and 22 recite the limitation of “has a shape that matches a shape of a portion of a crown of the extracted tooth” however the “extracted tooth” is undefined as it is not part of the apparatus nor of any particular shape or configuration as any given person’s anatomy and its condition is unique and undefined. For purposes of examination any prior art that has shapes which would provide for any shape of some possible person’s anatomy after some extraction of some tooth will be deemed to provide for the claim limitation.
Claims 21 recites the color of the tissue shaping feature matches a color of some extracted tooth, however such a color of some extracted tooth is undefined as a tooth that is extracted does not have any particular color. For purposes of examination any prior art with any color will be deemed to provide for the claim limitation.
Claim 23 recites limitations similar to claim 20 in relation to “the tissue shaping feature matches a shape of an interface surface of a three-dimensional (3D) tooth model of the extracted tooth” which again is undefined as some extracted tooth is not part of the system and has not recited or standard of shape and thus any model of and undefined extracted tooth would also be an undefined shape. For purposes of examination any prior art at has a shape of interface that could match some 3D model of some extracted tooth will be deemed to provide for the claim limitation.
Claim 24 recites the limitation of “the shape of the extracted tooth is based on a digital model of the extracted tooth” is unclear as linking the shape of some patient’s actual tooth that was previous extracted to have an anatomical shaped based on some digital model of their tooth that was to be extracted and results in a circular definition rendering the claim indefinite. For purposes of examination any prior art that provides for a space for a tooth implant to replace a previously removed tooth will be deemed to provide for the claim limitation as any tooth that had been extracted would have a shape that a digital model could be made from.
Any claim depending upon an indefinite claim is itself indefinite.
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 1-3, 5-8,10-14, 16-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuo et al. (US 2009/0291407 A1).
Regarding claims 1 and 11, Kuo discloses a dental apparatus configured to create an emergence profile for a tooth implant (title and abstract), the dental apparatus comprising:
a series of a shells configured to be removably placed on a patient’s dental arch (Fig. 1a element 100, abstract disclosing a “series of appliances”), the shell having an inner surface defining a plurality of cavities shaped and sized to accept teeth of the patient’s dental arch (Fig. 4a-e showing the inside of the shell having cavities for the teeth of a patient), wherein the inner surface is configured to apply a repositioning force to at least one tooth of the patient’s dental arch to reposition the at least one tooth from an initial position to a target position according to an orthodontic treatment plan (paragraph [0021] all disclosing appliances to reposition teeth); wherein the shell provides space for the tooth implant to replace an extracted tooth of the patient ( Fig. 2a-2c showing a vacancy between two adjacent teeth for the placement of a dental implant 214, Fig. 4a-e showing a space capable of being a space for a tooth implant 468 of some possible patient’s anatomy after a process of extraction),
and a tissue shaping feature configured to apply a shaping pressure to a gingiva interface region of the patient’s gingiva (Fig. 4a-e element 406/426/446/464/484 in combination with the healing abutment/cap of paragraph [0066] lines 4-8 and while their interaction is to “reduce pressure” this still includes some pressure from engagement between the shell and healing cap/abutment), wherein an interface surface of the tissue shaping feature that is configured contact the gingiva interface region of the patient’s gingiva has a shape that matches a shape of an expected tooth implant (Fig. 3 portion of element 302 that surround 308 or 348 is configured so as to contact a gingiva that would be in that region after a process of a tooth extraction, paragraph [0066] lines 6-8 disclosing a healing abutment/cap and thus would shaping the gums during the healing towards some shape and thus would completement a tooth implant, further the shape of the “expected tooth implant” is a broad limitation that includes an expected tooth implant that would match the shape of the portion of element 302/342 that surrounds 308 or 348, the use of the term “expected” does not require any particular tooth implant shape and as the portion of 302/342 that surround 308/348 respectively forms a shape where a tooth implant would be filled in then those shapes would match a shape of some tooth implant that is expected to be placed there as paragraph [0044] lines 1-6 disclose the creation of virtual final restorations, including crowns to be placed and thus would be tooth implants that would be expected to be placed).
The claims recite the limitations of the “ provides a space for the tooth to replace an extracted tooth of the patient” in claims 1 and 11. These limitations are being viewed as a product by process claim of merely reciting a process by which the product would be made discussed above, the presence of process limitations on product claims, which product does not otherwise patentably distinguish over prior art, cannot impart patentability to the product. In re Stephens 145 USPQ 656 (CCPA 1965). As the form to any shape or space for any purpose being based on the process of some tooth being extracted does not impart any patentability on the forms of the product as an extraction is a process and thus the making of some possible tooth extract is further a process. As such the structure which would result, a space for a vacancy capable of providing for a tooth implant or a shape that would be capable of matching some extraction are meet by any prior art provide a space and a shape which would match any possible tooth vacancy or gingiva configuration. As such the provided space and shapes of the tissue shaping features of Kuo to the tooth vacancy would read on the product by process structure.
Regarding claim 2, wherein the tissue shaping feature is attached to the shell (Figs. 4a-e elements 406/426/446/464/484 portions of the feature are attached to the shell)
Regarding claim 3, Kuo further discloses wherein the shaping pressure permits vascularization of gingival tissue at the gingiva interface region (paragraph [0066] lines 4-8 disclosing “reduce pressure” and healing and would provide for vascularized blood flow at a gingiva interface).
Regarding claim 5, Kuo further discloses wherein the shell and/or the tissue shaping feature is/are configured to reposition one or more teeth adjacent to an implant site to provide room for the tooth implant(paragraph [0104] all disclosing the neighboring teeth to the implant site are repositioned).
Regarding claim 6, Kuo further discloses wherein the shell is configured to reposition the at least one tooth to straighten the at least one tooth (Fig. 2c showing how repositioning of teeth includes straightening, as would depend on the patient’s anatomical needs).
Regarding claim 7, Kuo further discloses wherein the shell is configured to reposition the at least one tooth to straighten the at least one tooth, and wherein the shell and/or the tissue shaping feature is/are configured to reposition one or more teeth adjacent to an implant site to provide room for the tooth implant( paragraph [0104] all disclosing the neighboring teeth to the implant site are repositioned and space/room is made)
Regarding claim 8, Kuo further discloses wherein the tissue shaping feature comprises a crown portion having a shape that matches a shape of a crown of the tooth implant (Fig. 4b-e showing various crown portions with shapes that matches a crown shape that would be placed on the tooth implant 428/448/468/488).
Regarding claim 10, Kuo further discloses wherein the shell cooperates with the tissue shaping feature to apply the shaping pressure to the gingiva interface region of the patient’s gingiva (Fig. 4a-e element 406/426/446/464/484 in combination with the healing abutment/cap of paragraph [0066] lines 4-8 and while their interaction is to “reduce pressure” this still includes some pressure between the shell and healing cap/abutment by their interaction).
Regarding claim 12, Kuo further discloses wherein a first aligner of the series of aligners does not include a corresponding tissue shaping feature, and a second aligner of the series of aligners includes a corresponding tissue shaping feature (paragraph [0021] disclosing a first aligner would not have a tissue shaping feature as it would only be shape to reposition teeth to expose an implant site, paragraph [0084] disclosing the second aligner would have the abutment geometry for the tissue shaping feature).
Regarding claim 13, Kuo further discloses wherein a first set of aligners of the series of aligners is configured to reposition one or more teeth adjacent to the implant site to provide space for the tooth implant, and a second set of aligners includes the tissue shaping feature to shape the gingiva at the implant site(paragraph [0021] disclosing a first aligner would not have a tissue shaping feature as it would only be shape to reposition teeth to expose an implant site, paragraph [0084] disclosing the second aligner would have the abutment geometry for the tissue shaping feature of claim 11).
Regarding claim 14, Kuo further discloses wherein the shaping pressure permits vascularization of gingival tissue at the implant site paragraph [0066] lines 4-8 disclosing “reduce pressure” and healing and would provide for vascularized blood flow at a gingiva interface).
Regarding claim 16, Kuo further discloses wherein the tissue shaping feature is coupled to the at least one aligner such that the tissue shaping feature is removable from the patient’s mouth along with the at least one aligner(Figs. 4a-e elements 406/426/446/464/484 portions of the feature are attached to the shell)
Regarding claim 17, Kuo further discloses wherein the tissue shaping feature is configured to engage with the at least one aligner (Fig. 4a-e element 406/426/446/464/484 in combination with the healing abutment/cap of paragraph [0066] lines 4-8 and while their interaction is to “reduce pressure” this still includes some pressure from engagement between the shell and healing cap/abutment).
Regarding claim 18, Kuo further discloses wherein the tissue shaping feature is configured to engage with a healing abutment attached to a body portion of the tooth implant that is implanted within the patient’s jaw(Fig. 4a-e element 406/426/446/464/484 in combination with the healing abutment/cap of paragraph [0066] lines 4-8 and while their interaction is to “reduce pressure” this still includes some pressure from engagement between the shell and healing cap/abutment).
Regarding claim 19, Kuo further discloses wherein the tissue shaping feature comprises a crown portion having a shape that matches shape of a crown of the tooth implant (paragraph [0066] the healing abutment/cap would match the shape of a crown to the implant shape it would be attached too).
Regarding claim 20, Kuo further discloses wherein the crown portion of the tissue shaping feature has a shape that matches a shape of a portion of a crown of the extracted tooth (Fig. 4b-e showing various crown portions with shapes that would match to a crown of an extracted tooth if one was extracted in the regions of the tooth implant 428/448/468/488).
Regarding claim 21, Kuo further discloses wherein the tissue shaping feature has a color that matches a color of an extracted tooth or other teeth of the patient (paragraph [0067] lines 8-10 disclosing a “tooth-colored material” and thus would match a tooth color of an extracted tooth or other teeth).
Regarding claim 22, Kuo further discloses where the shape of the interface surface of the tissue shaping feature has a shape that matches a shape of a portion of a crown of the extracted tooth (Fig. 2 element 214, paragraph [0035] disclosing the creation of at space in the vacancy between to two teeth would be based on a virtual treatment plan with implant placement and final restoration design, Fig. 4b/c elements 406/426/446 have shapes that would match some tooth crown portion of some extracted tooth when some process of extraction some possible patient’s tooth would be performed, such a limitation is being treated as a product by process limitation).
Regarding claim 23, Kuo further discloses where the shape of the interface surface of the tissue shaping feature matches a shape of an interface surface of a three-dimensional (3D) tooth model of the extracted tooth (Fig. 2 element 214, paragraph [0035] disclosing the creation of at space in the vacancy between to two teeth would be based on a virtual treatment plan with implant placement and final restoration design, Fig. 3a/c element of the shape around 308/348 would match a shape of some possible 3d model of some possible extracted tooth in some extraction process. The limitation being treated as a product by process, a product shaped off a process of extraction from some unknown patient’s unknown anatomy would have a structural shape as shown in Kuo, the extraction is not part of the apparatus nor is some 3d model a part of the apparatus).
Regarding claim 24, Kuo further discloses a shape of the extracted tooth shape of the apparatus is based on a digital model of the extracted tooth (Fig. 4b/c there being a tooth shape 424/444 which are product, the limitation of being shape based on a modelling of a process of extraction for a tooth would result in a product as cited, Fig. 2b showing the use of digital models of teeth in a vacancy 214).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P SAUNDERS whose telephone number is (571)270-3250. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edelmira Bosques can be reached at (571) 270-5614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.P.S/Examiner, Art Unit 3772 06/26/2026
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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