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 .
Claim Objections
Claims 1-4 and 6-20 is objected to because of the following informalities:
Claim 1, line 3 change “Obtaining” to “obtaining”.
Claim 1, line 5 change “Determining” to “determining” .
Claim 1, line 7 change “Placing” to “placing”.
Claim 1, line 10 change “Optionally” to “optionally”.
Claim 1, line 13 change “Performing” to “performing”.
Claim 1, line 15 change “Obtaining” to “obtaining”.
Claim 1, line 18 change “Manufacturing” to “manufacturing”.
Claim 1, line 20 change “Fitting” to “fitting”.
Claims 2-4 and 6-10. line 1-2 change “prosthetics in a prosthetic field of a patient” to “prosthetic in the prosthetic field of the patient”.
Claim 11, line 4 change “ A base” to “a base”.
Claim 11, line 6 change “A pre-surgical” to “a pre-surgical”.
Claim 12-15, lines 1-2 “a prosthetic in a prosthetic field” to “prosthetic in the prosthetic field of the patient”.
Claim 16, line 3 change “Obtaining” to “obtaining”.
Claim 16, line 5 change “Determining” to “determining”.
Claim 16, line 7 change “Placing” to “placing”.
Claim 16, line 10 change “Optionally” to “optionally”.
Claim 16, line 13 change “Performing” to “performing”.
Claim 16, line 15 change “Obtaining” to “obtaining”.
Claim 16, line 18 change “Manufacturing” to “manufacturing”.
Claim 16, line 20 change “Fitting” to “fitting”.
Claim 17-20, lines 1-2 “a prosthetic in a prosthetic field” to “prosthetic in the prosthetic field of the patient”.
Appropriate correction is required.
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 1-4 and 6-15 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, lines 10-11. recites “a prosthetic field”, it is unclear if this is the same prosthetic field as recited in lines 1-2. For the purpose of examination, the prosthetic field of lines 1-2 are considered the same as the prosthetic field of lines 10-11.
Claims 2-4 and 6-10 are reject based on claim dependency on claim 1.
Claim 3 recites “a base patient image”, it is unclear if that is the same base image created in the pre-surgical physiologic data obtaining step of claim 1 or an additional or different base image. For the purpose of examination, the limitation is interpreted as the same base image as recited in claim 1.
Claim 8 recites the limitation "the preliminary oral prosthetic" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 11, line 4 change “a prosthetic field”, it is unclear if this is the same prosthetic field as recited in lines 1-2. For the purpose of examination, the prosthetic field of lines 1-2 are considered the same as the prosthetic field of line 4.
Claim 12-15 are rejected based on claim dependency on claim 11.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
the claimed invention is directed to non-statutory subject matter. The claims 11-15 does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are drawn to “registration images used for preparing and fitting a prosthetic in a prosthetic field of a patient using pre-surgical fiducial markers”, the claim does not disclose any structure elements such as medium or method of presenting the images or that contains the images, such as a computer, hard drive or even paper. As such the claimed product does not have a physical or tangible form and is therefore considered “data per se” and therefore is not directed to any of the stator categories (see MPEP 2106.03 I).
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 7-8, 10-12, 14, 16, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Neill (US 2018/0206951).
Regarding claim 1, O’Neill discloses a protocol for preparing and fitting a prosthetic in a prosthetic field of a patient using pre-surgical fiducial markers (abstract discloses the method including Scannable Temporary Anatomic References, STAR, being used in a pre-planned restoration, wherein the restoration is interpreted as the prosthetic and the prosthetic field is the jaw or mouth of the patient) comprising the steps of:
obtaining pre-surgical physiologic data of the patient in a prosthetic field sufficient to create a base patient image of the prosthetic field (par 69 discloses the methodology begins with “usual manner of diagnostics and initial restoration design”, this methodology is defined in par 23 which discloses a collection of photographs, CBCT etc. of the patient’s existing dental situation to create a digital dental clone in a highly precise software generated depiction) ;
determining fiducial marker placement in physiologic structure within the prosthetic field of the patient which is to be unchanged by a planned surgery (par 70-71 discloses determining the position of the markers “STAR” based on the existing teeth stability, such as on the skeletally support to provide reliable frame of reference);
placing fiducial markers in the determined fiducial marker placement in physiologic structure within the prosthetic field which is to be unchanged by a planned surgery (par 70-71 discloses placing a minimum of three skeletal supported STAR on the upper or lower jaw away from the area of planned surgical fixation sites which would be unchanged by surgical intervention);
optionally obtaining pre-surgical physiologic data of the patient in a prosthetic field with the fiducial markers in place sufficient to create a base patient image of the prosthetic field with fiducial markers being restored (par 71 discloses once the STAR is installed, performing an intraoral scan to obtain the arch or arches, note this step is optional and NOT required by the claim);
performing surgery altering physiologic structure of the patient within the prosthetic field (par 72 discloses the placement of the dental implant or the extraction of the dentition without the disruption of the STAR);
Obtaining post-surgical physiologic data of the patient in a prosthetic field with the fiducial markers in place sufficient to create a post-surgical patient image of the prosthetic field with fiducial markers (par 74 discloses after the implants have all been placed and are ready for immediate restoration/loading the arch is scanned again with the implant and skeletally supported STAR, note this step is optional and NOT required by the claim);
manufacturing a final prosthetic based upon post-surgical patient image of the prosthetic field with fiducial markers (par 77-79 disclose the use of the imaging and STAR position information to fabricate restorations and par 84 discloses creating a final restoration based on the STAR information); and
fitting the final prosthetic in the prosthetic field based upon post-surgical patient image of the prosthetic field with fiducial markers (par 77-83 discloses the importing of the imaging and designed restoration to fit a physical verification jig created by a 3D model on the implant).
Regarding claim 2, O’Neill discloses the prosthetic is an oral prosthetic (par 20 discloses the implant-supported dental restoration) and the prosthetic field is the oral cavity of the patient (par 18 discloses the oral space including teeth, soft tissue and/or hard tissue).
Regarding claim 4, O’Neill discloses the step of obtaining pre-surgical physiologic data of the patient includes digital dental information (par 23 discloses various physiological data that is in a digital format such as DICOM or jpeg).
Regarding claim 7, O’Neill discloses the base patient image of the prosthetic field is used to design a preliminary oral prosthetic for the patient (par 24 discloses after the creating a digital clone from collected data, a trial smile or esthetic mock up is created to visualize a planned restoration).
Regarding claim 8, O’Neill discloses the step of manufacturing the final prosthetic based upon post-surgical patient image of the prosthetic field with fiducial markers includes milling the preliminary oral prosthetic (par 26 discloses the files format enabling the design/restoration being precisely milled the design created in par 24-26).
Regarding claim 10, O’Neill discloses the step of performing surgery altering physiologic structure of the patient within the prosthetic field, includes installing implants in the oral cavity wherein the post-surgical patient image of the prosthetic field with fiducial markers includes images of the implants (par 72 discloses the surgery is implanting an implant into the oral cavity and the taking of pictures with the STAR and implant, par. 74).
Regarding claim 11, O’Neill discloses registration images used for preparing and fitting a prosthetic in a prosthetic field of a patient using pre-surgical fiducial markers (abstract discloses a method of designing and implanting a restoration using images collected during a procedure using Scannable Temporary Anatomic References), the registration images being a composite of comprising:
a base patient image of a prosthetic field of the patient obtained with pre- surgical physiologic data of the patient in the prosthetic field (par 69 discloses the collection of the diagnostic information prior to surgery, par 23 discloses a collection of photographs, CBCT etc. of the patient’s existing dental situation to create a digital dental clone in a highly precise software generated depiction, the clone being interpreted as a base patient image) ;
a pre-surgical base patient image of the prosthetic field with fiducial markers (par 71 discloses the intraoral scan of the placed STAR, the image being the pre-surgical base patient image as seen in figure 1), wherein fiducial markers in the determined fiducial marker placement in physiologic structure within the prosthetic field which is to be unchanged by a planned surgery (the provided limitation is interpreted as a functional limitation/intended use of the pre-surgical base patient image, however the prior art discloses in par 70-71 discloses placing a minimum of three skeletal supported STAR on the upper or lower jaw away from the area of planned surgical fixation sites which would be unchanged by surgical intervention) , and the pre-surgical base patient image of the prosthetic field with fiducial markers is obtained with physiologic data of the patient in a prosthetic field with the fiducial markers in place (the provided limitation is interpreted as a functional limitation/intended use of the pre-surgical base patient image, however the prior art discloses in par 70-71 discloses determining the position of the markers STAR” based on the existing teeth stability, such as on the skeletally support to provide reliable frame of reference); and
a post-surgical patient image of the prosthetic field with fiducial markers (par 74 discloses after the implants have all been placed and are ready for immediate restoration/loading the arch is scanned again with the implant and skeletally supported STAR), whereby manufacturing of a final prosthetic is based upon post-surgical patient image of the prosthetic field with fiducial markers and fitting the final prosthetic in the prosthetic field is based upon post-surgical patient image of the prosthetic field with fiducial markers (the provided limitation is interpreted as a functional limitation/intended use of the post-surgical base patient image, however the prior art discloses in par 77-79 disclose the use of the imaging and STAR position information to fabricate restorations and par 84 discloses creating a final restoration based on the STAR information)
Regarding claim 12, O’Neill discloses the prosthetic is an oral prosthetic (par 20 discloses the implant-supported dental restoration) and the prosthetic field is the oral cavity of the patient (par 18 discloses the oral space including teeth, soft tissue and/or hard tissue).
Regarding claim 14, O’Neill discloses at least one of the images are formed from data including digital dental information (par 23 discloses various physiological data that is in a digital format such as DICOM or jpeg).
Regarding claim 16, O’Neill discloses a protocol for preparing and fitting an oral prosthetic in a patient using pre-surgical fiducial markers (abstract discloses the method including Scannable Temporary Anatomic References, STAR, being used in a pre-planned restoration, wherein the restoration is interpreted as the prosthetic and the prosthetic field is the jaw or mouth of the patient) comprising the steps of:
obtaining pre-surgical physiologic data of the patient in a prosthetic field sufficient to create a base patient image of the prosthetic field (par 69 discloses the methodology begins with “usual manner of diagnostics and initial restoration design”, this methodology is defined in par 23 which discloses a collection of photographs, CBCT etc. of the patient’s existing dental situation to create a digital dental clone in a highly precise software generated depiction);
determining fiducial marker placement in physiologic structure within the prosthetic field of the patient which is to be unchanged by a planned surgery (par 70-71 discloses determining the position of the markers “STAR” based on the existing teeth stability, such as on the skeletally support to provide reliable frame of reference);
placing fiducial markers in the determined fiducial marker placement in physiologic structure within the prosthetic field which is to be unchanged by a planned surgery (par 70-71 discloses placing a minimum of three skeletal supported STAR on the upper or lower jaw away from the area of planned surgical fixation sites which would be unchanged by surgical intervention);
optionally obtaining pre-surgical physiologic data of the patient in a prosthetic field with the fiducial markers in place sufficient to create a base patient image of the prosthetic field with fiducial markers (par 71 discloses once the STAR is installed, performing an intraoral scan to obtain the arch or arches);
performing surgery altering physiologic structure of the patient within the prosthetic field (par 72 discloses the placement of the dental implant or the extraction of the dentition without the disruption of the STAR);
obtaining post-surgical physiologic data of the patient in a prosthetic field with the fiducial markers in place sufficient to create a post-surgical patient image of the prosthetic field with fiducial markers (par 74 discloses after the implants have all been placed and are ready for immediate restoration/loading the arch is scanned again with the implant and skeletally supported STAR);
manufacturing a final prosthetic based upon post-surgical patient image of the prosthetic field with fiducial markers (par 77-79 disclose the use of the imaging and STAR position information to fabricate restorations and par 84 discloses creating a final restoration based on the STAR information); and
fitting the final prosthetic in the prosthetic field based upon post-surgical patient image of the prosthetic field with fiducial markers (par 77-82 discloses the importing of the imaging and designed restoration to fit a physical verification jig created by a 3D model on the implant).
Regarding claim 18, O’Neill discloses the base patient image is formed from data including digital dental information (par 23 discloses various physiological data that is in a digital format such as DICOM or jpeg).
Regarding claim 20, O’Neill discloses the step of performing surgery altering physiologic structure of the patient within the prosthetic field, includes installing implants in the oral cavity wherein the post-surgical patient image of the prosthetic field with fiducial markers includes images of the implants (par 72 discloses the surgery is implanting an implant into the oral cavity and the taking of pictures with the STAR and implant).
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 3, 6, 9, 13, 15, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over O’Neill et al as applied to claims 2 and 12 above, and further in view of Mirelez JR. et al (US 2022/0160478).
Regarding claim 3, O’Neill discloses the claimed invention as set forth above in claim 1, but fails to disclose the step of obtaining pre-surgical physiologic data of the patient in a prosthetic field sufficient to create a base patient image includes data sufficient to establish frontal smile, frontal retracted smile, smiling right quad, smiling left quad, upper jaw, lower jaw, left profile view.
Mirelez teaches a step of collecting pre-surgical physiologic data of the patient in a prosthetic field sufficient to create a base patient image includes data sufficient to establish frontal smile, frontal retracted smile, smiling right quad, smiling left quad, upper jaw, lower jaw, left profile view (par 80-81 discloses preoperative records of the patient being taken with CBCT of mandible or maxilla, IOS of the maxilla and mandible , FS of the bite with retractor and repose, with a natural smile and exaggerated which would result with smiling right and left quads) for the purpose of aiding in the creation of a pre-surgical dental restoration design (par 81).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify O’Neill teaches the step of obtaining pre-surgical physiologic data of the patient in a prosthetic field sufficient to create the base patient image includes data sufficient to establish frontal smile, frontal retracted smile, smiling right quad, smiling left quad, upper jaw, lower jaw, left profile view as taught by Mirelez for the purpose of aiding in the creation of a pre-surgical dental restoration design.
Regarding claim 6, O’Neill discloses the claimed invention as set forth above in claim 2, but fails to disclose the step of obtaining pre-surgical physiologic data of the patient includes facial recognition scans.
However, Mirelez teaches pre-surgical physiologic data of the patient includes facial recognition scans (par 10 discloses the use of facial scans to determine the natural posture of the head ) for the purpose of providing the natural posture of the head which enables designing a proper smile (par 10).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify O’Neill to have the step of obtaining pre-surgical physiologic data of the patient includes facial recognition scans as taught by Mirelez for the purpose of providing the natural posture of the head which enables designing a proper smile.
Regarding claim 9, O’Neill discloses the step of fitting the final prosthetic in the prosthetic field based upon post-surgical patient image includes (par 79 discloses the patient waiting for the final restoration to be created and par 83 discloses the restoration being fit and checked for adaption by the dentist), but fails to disclose the step includes waiting a set period of time for post-surgical healing and tissue stability before a final fitting.
However, Mirelez teaches a step of fitting the final prosthetic including a waiting a set period of time for post-surgical healing and tissue stability before a final fitting (par 76 discloses the healing process of 3-6 months during the process of the manufacturing the dental restoration).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify O’Neill to include the step includes waiting a set period of time for post-surgical healing and tissue stability before a final fitting as taught by Mirelez for the purpose of enabling sufficient stability of the dental prosthetic.
Regarding claim 13, O’Neill discloses claimed invention as set forth above in claim 12, but fails to disclose the base patient image is formed from data sufficient to establish frontal smile, frontal retracted smile, smiling right quad, smiling left quad, upper jaw, lower jaw, left profile view.
Mirelez teaches a base patient image includes data sufficient to establish frontal smile, frontal retracted smile, smiling right quad, smiling left quad, upper jaw, lower jaw, left profile view (par 80-81 discloses preoperative records of the patient being taken with CBCT of mandible or maxilla, IOS of the maxilla and mandible , FS of the bite with retractor and repose, with a natural smile and exaggerated which would result with smiling right and left quads) for the purpose of aiding in the creation of a pre-surgical dental restoration design (par 81).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify O’Neill teaches the base patient image includes data sufficient to establish frontal smile, frontal retracted smile, smiling right quad, smiling left quad, upper jaw, lower jaw, left profile view as taught by Mirelez for the purpose of aiding in the creation of a pre-surgical dental restoration design.
Regarding claim 15, O’Neill discloses claimed limitations as set forth above in claim 12, but fails to disclose at least one of the images are formed from data including facial recognition scans.
However, Mirelez teaches the images being formed of data including facial recognition scans (par 10 discloses the use of facial scans to determine the natural posture of the head ) for the purpose of providing the natural posture of the head which enables designing a proper smile (par 10).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify O’Neill to have at least one of the images are formed from data including facial recognition scans as taught by Mirelez for the purpose of providing the natural posture of the head which enables designing a proper smile.
Regarding claim 17, O’Neill discloses the claimed invention as set forth above in claim 16, but fails to disclose the base patient image is formed from data sufficient to establish frontal smile, frontal retracted smile, smiling right quad, smiling left quad, upper jaw, lower jaw, left profile view.
Mirelez teaches a base patient image includes data sufficient to establish frontal smile, frontal retracted smile, smiling right quad, smiling left quad, upper jaw, lower jaw, left profile view (par 80-81 discloses preoperative records of the patient being taken with CBCT of mandible or maxilla, IOS of the maxilla and mandible , FS of the bite with retractor and repose, with a natural smile and exaggerated which would result with smiling right and left quads) for the purpose of aiding in the creation of a pre-surgical dental restoration design (par 81).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify O’Neill teaches the base patient image includes data sufficient to establish frontal smile, frontal retracted smile, smiling right quad, smiling left quad, upper jaw, lower jaw, left profile view as taught by Mirelez for the purpose of aiding in the creation of a pre-surgical dental restoration design.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pope (US 2024/0115359) discloses an intraoral scanning protocol which includes markers and scanning to determine topological and structural information for dental surgeries (abstract).
Bell (US 2021/0244515) discloses a scanning protocol which includes the placement of markers to register the bite and track the position of the jaw for dental treatment and orthodontics (abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANNEL N BELK whose telephone number is (571)272-9671. The examiner can normally be reached Mon. -Fri. 11:30 am - 3:30 pm.
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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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/S.N.B./ Examiner, Art Unit 3772
/HEIDI M EIDE/ Primary Examiner, Art Unit 3772
7/20/2026
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