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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, claim 1, in the reply filed on 8/4/2026 is acknowledged.
Claim 2 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/4/2026.
Power of Attorney
The examiner was not permitted to discuss an examiner’s amendment for the issues below because it appears applicant has legal representation but a valid power of attorney has not been filed in the present application. Providing representative information in an Application Data Sheet (ADS) does not constitute a power of attorney. See 37 CFR 1.76(b)(4) and MPEP § 408. For information on appointing a power of attorney, see MPEP § 402.02 et seq.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, line 4, “the surface configuration” is believed to be in error for --a surface configuration--.
In claim 1, line 7, “the location” is believed to be in error for --a location--.
In claim 1, line 10, “a patient’s mandible” is believed to be in error for --the patient’s mandible--.
In claim 1, line 17, “a fibula flap” is believed to be in error for --the fibula flap--.
In claim 1, line 18, “the physical model” is believed to be in error for --the physical 3-D model--.
In claim 1, line 20, “the 3-D model” is believed to be in error for --the physical 3-D model--.
In claim 1, line 26, “the 3-D physical model” is believed to be in error for --the physical 3-D model--.
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.
Claim 1 is 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, line 26 (step (m)), recites “transitioning the reconstruction assembly from the 3-D physical model onto the patient”. This is unclear because the reconstruction assembly is defined in step (b) as comprising a fixation implant, a dental prosthesis, anterior and posterior positioning extensions, implant posts, and a fibula flap, but step (l) removes the positioning extensions from the dental prosthesis. It is therefore unclear if the positioning extensions are part of the reconstruction assembly that is transitioned onto the patient in step (m). If the positioning extensions are not placed onto the patient, step (m) could be amended to recite each of the parts of the reconstruction assembly listed in step (b) minus the positioning extensions.
For applicant’s convenience, proposed amendments to claim 1 are shown below.
1. A mandible reconstruction method comprising the steps of:
(a) creating a virtual 3-D model of a patient’s mandible that has been resected,
(b) designing components of a reconstruction assembly comprising a fixation implant contoured to a surface configuration of the patient’s remaining bone, a dental prosthesis, anterior and posterior positioning extensions joined to the dental prosthesis, implant posts, and a fibula flap,
(c) determining a location for positioning recesses to receive the anterior and posterior positioning extensions and screw apertures for affixation of the fixation implant in the virtual 3-D model,
(d) creating a physical 3-D model of [[a]] the patient’s mandible that has been resected, the physical 3-D model including the positioning recesses to receive the anterior and posterior positioning extensions and screw apertures for affixation of the fixation implant
(e) manufacturing the fixation implant, dental prosthesis, anterior and posterior positioning extensions joined to the dental prosthesis, and implant posts,
(f) inserting the implant posts into a fibula,
(g) harvesting segments from the fibula,
(h) affixing the fibula segments to the fixation implant to create [[a]] the fibula flap,
(i) positioning the dental prosthesis onto the physical 3-D model such that the positioning extensions are received by the positioning recesses,
(j) affixing the fixation implant and fibula flap onto the physical 3-D model with the implant posts extending into bores in the dental prosthesis,
(k) applying resin to cement the dental prosthesis to the implant posts, the positioning extensions ensuring the correct location and orientation of the dental prosthesis relative to the fixation implant,
(l) removing the positioning extensions from the dental prosthesis, and
(m) transitioning the fixation implant, dental prosthesis, implant posts, and fibula flap from the physical 3-D
Allowable Subject Matter
Claim 1 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.
It appears claim 2 would be allowable upon being amended to positively recite the 3-D physical model of the patient’s mandible comprising the positioning recesses. Note that claim 2, line 2 should recite --a surface configuration-- instead of “the surface configuration”.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is considered Qaisi et al. “Fibula Jaw in a Day: State of the Art in Maxillofacial Reconstruction”, J Oral Maxillofac Surg 74:1284.e1-1284.e15, 2016 (hereafter referred to as Qaisi). Qaisi discloses a mandible reconstruction method comprising virtual 3D modeling and using a physical 3D model to configure a reconstruction assembly comprising a fixation implant, a dental prosthesis, implant posts, and a fibula flap (at least figs. 9A-9D), but Qaisi does not disclose anterior and posterior positioning extensions joined to the dental prosthesis or positioning recesses to receive the anterior and posterior positioning extensions and screw apertures for affixation of a fixation implant in the physical 3-D model. Toranto US 2022/0362023 discloses positioning extensions 4404 joined to a reconstruction assembly (fig.44), but does not disclose a physical 3-D model comprising recesses to receive the positioning extensions and does not disclose the step of removing the positioning extensions. Therefore, the prior art does not disclose, teach, or suggest the mandible reconstruction method as recited in claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
