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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/08/2025 has been entered.
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.
Claim 22 is 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 22 recites “during step d], refining the digital impression data includes a further scan from which the characteristic shape data is obtained”. In the remarks, applicant discloses support for the claim limitation is implied by the specification needing the characteristic shape data to achieve the step of refinement and the disclosure of scanning during other information/data gathering steps. However, the specification fails to mention or disclose further scanning to obtain additional information. The disclosure regarding characteristic shape data requires it be pre-existing/predetermined (par 18 and 105) and provides known geometries “pyramidal frustum; substantially pyramidal frustum; conical frustum; or substantially conical frustum” (see par 32). The shape data being pre-existing or predetermined does not necessitate further scanning and other methods of obtaining the characteristic shape data such exist other than scanning, such as programing or entering the known shape or dimensions into the processing software. As such, support for the “further scan from which the characteristic shape data is obtained” is considered new matter not in compliance with written description requirement.
Claim Rejections - 35 USC § 103
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 11-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over DeClerck (US 2005/0112524) in view of Wichmann et al (US 2007/0077535) and Schulter et al (US 2012/0088208).
Regarding claim 11, DeClerck discloses a method of creating a dental implant drill-guide for guiding the drilling of dental-implant cavities in an edentulous area of a maxillary or mandibular arch (par 8-15 discloses the creation of an aligning plate to the jaw to guide the drilling of implants needed to support a dental superstructure, the example provided is on a “toothless lower jaw 1”, see figure 1 and par 24), the method comprising the steps of:
inserting only a plurality of apical parts of two-part orthodontic screws into the edentulous area of a maxillary or mandibular arch of a patient (screw 2 portion of the assembled screw 2 and bolt 14, see figure 1 and par 25; the limitation is interpreted as the plurality of apical parts of two-part screws are the only component being inserted into the osseous tissue, which is disclosed in par 26 ), such that the two-part orthodontic screws engage with the osseous tissue of the edentulous area of the maxillary or mandibular arch and extend through the gingival mucosa (see figure 5 and par 44 which discloses the screw passing the gum of the patient into the bone of the jaw);
obtaining digital impression data of the edentulous area of the maxillary or mandibular arch inclusive of the plurality of two-part orthodontic screws to form a maxillary or mandibular image (par 26-29 discloses a dental impression being taken by any known manner to determine the position of the upper and lower jaw to create an articulate wax model which is used to create a provisional model, then par 30 discloses a three-dimensional image being created with the screws 2 and model attached to the jaw of the patient);
determining dental implant position data for the insertion of one or more dental implants into the edentulous area of the maxillary or mandibular arch relative to the positions of the plurality of two-part orthodontic screws from the digital impression data (par 31-33 disclose the use of the mucosal impression data to collect a three dimension image of the edentulous arch and based on the anatomical structure and observed structure including the screw placement to determine a suitable orientation and dimension of the drilled holes through the bone of the jaw ); and
using a computer assisted manufacturing process, creating a dental implant drill-guide from the determined dental implant position data, the dental implant drill- guide having a plurality of orthodontic screw-seats which correspond to the said plurality of two-part orthodontic screws (par 33 discloses creating the aligning plate 3 based on the suitable orientation and diameter of the implant holes and par 45 discloses the aligning plate having an opening which corresponds to the shape of the screw).
DeClerck fail to disclose pre-operatively creating image data of an edentulous maxillary or mandibular arch using a radiographic imager prior to insertion of a plurality of orthodontic screws, to determine an optimal position for the plurality of orthodontic screws and/or an optimal position of the dental-implant cavities and refining the digital impression data based on characteristic shape data corresponding to the two-part orthodontic screws and using the refined impression data to determine dental implant position data.
Wichmann teaches preoperatively creating image data of an edentulous maxillary or mandibular arch using radiographic imaging prior to insertion of a plurality of orthodontic screws (par 4 discloses the measurement of the patient’s existing bone structure prior to diagnosis, the imaging performed by means of x ray templates; par 6 discloses the jaw is edentulous) and to determine an optimal position for the plurality of orthodontic screws and/or an optimal position of the dental-implant cavities (par 4 discloses the use of the images to produce a treatment schedule and a drilling template is produced based on that and used during the operation according to preimplant diagnosis).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify DeClerck to include pre-operatively creating image data of an edentulous maxillary or mandibular arch using a radiographic imager prior to insertion of a plurality of orthodontic screws, to determine an optimal position for the plurality of orthodontic screws and/or an optimal position of the dental-implant cavities as taught by Wichmann for the purpose of enabling accurate placement of dental implant and screws.
Schulter teaches refining the impression data based on characteristic shape data corresponding to an attached, spherical surface portion attached to an alignment post, and using the refined impression data to determine dental implant position data (fitting 152 has a particular shape and orientation which is frustum-conical and conical and the computer 186 after receiving the scan and surface information uses predetermined geometrical shapes and orientations to replace the scanned shape information, see par 127) for the purpose of providing a more accurate position and orientation for the matching surface of the fitting (par 127).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify DeClerck by including a step of refining the impression data based on characteristic shape data corresponding to the attached two -part orthodontic screws as disclosed by Schulter for the purpose of proving more accurate position and orientation for the two part orthodontic screw and therefore use the more accurate information in the determination of the dental implant position.
Regarding claim 12, DeClerck discloses the coronal part (14) of each of the two-part orthodontic screws (2), has a screw-thread which is receivable within an apical part of the two- part orthodontic screw (see figure 5).
Regarding claim 13, DeClerck/Schulter discloses the claimed invention as set forth above in claim 11. However, Schulter further teaches the characteristic shape data relates to a shape of the two-part orthodontic screw which is: pyramidal frustum; substantially pyramidal frustum; conical frustum; or substantially conical frustum, (par 127-128 disclose the geometric shape frusto-conical) for the reasons set forth above.
Regarding claim 14, DeClerck further discloses during step a], the two-part orthodontic screws (2) are inserted in a triangular arrangement into the edentulous area of the maxillary or mandibular arch (see figure 1).
Regarding claim 16, DeClerck further discloses during step b], image data of the edentulous area of the maxillary or mandibular arch is used alongside the impression data to form the maxillary or mandibular image (par 30 discloses taking three-dimensional images of the patients jaw with the screws 2 and a provisional model which is a representation of the impression data to create images, par 31-33 discloses the images are processed electronically and take into consideration anatomical structures of the jaw).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over DeClerck in view of Wichmann et al and of Schulter et al as applied to claim 11 above, and further in view of Sachdeva et al (US 5,697,779).
Regarding claim 15, DeClerck/Wichmann/Schulter disclose the claimed invention as set forth above in claim 11. DeClerck further discloses a maximum length of the orthodontic screw being 5 mm (par 25) and the screws extending into the osseous tissue of an edentulous maxillary or mandibular arch (see figure 5 and par 44), but fails to disclose the plurality of orthodontic screws are inserted between 2 and 3 millimeters deep
However, Sachdeva teaches the insertion of temporary implants as an anchor in the mouth, specifically orthodontic screws which are inserted between 2-3 millimeters deep for the purpose of providing necessary support with little bone integration making it easier to remove after treatment (col 4, lines 17-22).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify DeClerck to have the orthodontic screws inserted between 2-3 mm depth for the purpose of providing necessary support with minimal bone integration, which makes removing the screws easier after the procedure.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over DeClerck in view of Wichmann et al and of Schulter et al as applied to claim 11 above, and further in view of Lawitschka et al (US 2012/0035889).
Regarding claim 22, DeClerck/Wichmann/Schulter disclose the claimed invention as set forth above in claim 11, but fails to disclose refining the digital impression data includes a further scan from which the characteristic shape data is obtained.
However, Lawitschka teaches obtaining shape scan data by scanning (par 14) for the purpose of determining the position and orientation of the dental implant (par 14).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify DeClerck/Wichmann/Schulter to have the refining the digital impression data step to include scanning to obtain the characteristic shape data as taught by Lawitschka for the purpose of determining the position and orientation of the orthodontic screw.
Response to Arguments
Applicant's arguments filed 12/08/2025 have been fully considered, but they are not persuasive.
Applicant argues on par 6-7 of the Remarks that Schulter teaches away from the limitation “refining the digital impression data based on characteristic shape data corresponding to the two-part orthodontic screws”, by disclosing the use of the fitting to identify the shape and position of the fittings, and that the refinement of the present application is sufficient to not require an additional component. The examiner does not find the argument persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Schulter teaches refining the impression data based on characteristic shape data corresponding to an attachment, specifically a spherical surface portion attached to an alignment post, and using the refined impression data to determine dental implant position data (fitting 152 has a particular shape and orientation which is frustum-conical and conical and the computer 186 after receiving the scan and surface information uses predetermined geometrical shapes and orientations to replace the scanned shape information, see par 127). As such the addition of the component in Schulter does not eliminate the teaching of using characteristic shape data to refine impression data as set forth in par 127.
Conclusion
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/S.N.B./ Examiner, Art Unit 3772
/HEIDI M EIDE/ Primary Examiner, Art Unit 3772
1/2/2026