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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the limitations from claims 4-8: “making an incision along the lower jaw's gum line: creating a mucoperiosteal flap: cutting a lateral bone window to access the inferior alveolar nerve; mobilizing and retracting the nerve to a lateral position using the first instrument BA.P.LAT 1 or the second instrument BA.P-LAT 2: preparing the bone for implant placement; placing the implants; positioning the nerve near the implants, with the nerve protected by the third instrument BA.P.LAT 3: replacing and stabilizing the cortical bone windows using bone plates and screws; and, closing the surgical site”, (see claim 4 lines 3-14), which is not presented in any of the figures of 12/30/2023, must be shown or the feature(s) canceled from the claim(s). Note that the specification does provide support for this limitation (only via the recitation of claim 4) but does not provide further detail regarding the implants (e.g., number or type), bone plates (e.g., number or type) and screws (e.g., number or type) or to the procedure itself. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-8 are objected to because of the following informalities:
Claim 1 line 1 recites “&” instead of “and”. Please amend claim 1 line 1 to recite “and” to overcome this objection. Appropriate correction is required.
Claim 4 lines 6 and 10 recite “the nerve”. However, this limitation appears to refer back to “the inferior alveolar nerve” in line 5. To overcome this objection, line 6 must be amended to recite “mobilizing and retracting the inferior alveolar nerve to a lateral position using the first instrument” and line 10 amended to recite “positioning the inferior alveolar nerve near the implants, with the inferior alveolar nerve protected by the third” to keep the terminology consistent.
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 1-8 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 1-8 recite instruments BA.P.LAT1, BA.P.LAT2 and BA.P.LAT3. As best understood, there is no language/guidance provided within the Specification as to what “BA.P.LAT” means. Therefore, this term is indefinite because the Specification does not clearly define the term. For purposes of examination, this terminology will be interpreted as a label assigned to a respective instrument.
Claim 1 recites the limitation "the first instrument BA.P.LAT 1" in line 3. There is insufficient antecedent basis for this limitation in the claim as this limitation was not introduced prior to this recitation. To overcome this rejection, please amend this limitation to recite “a first instrument BA.P.LAT 1” in line 3.
Claim 1 recites the limitation "the first instrument BA.P.LAT 2" in line 5. There is insufficient antecedent basis for this limitation in the claim as this limitation was not introduced prior to this recitation. To overcome this rejection, please amend this limitation to recite “a first instrument BA.P.LAT 2” in line 5.
Claim 1 recites the limitation "the first instrument BA.P.LAT 3" in line 7. There is insufficient antecedent basis for this limitation in the claim as this limitation was not introduced prior to this recitation. To overcome this rejection, please amend this limitation to recite “a first instrument BA.P.LAT 3” in line 7.
Claim 2 recites “where all instruments, including the first instrument BA.P.LAT 1, the second instrument BA.P.LAT 2, and the third instrument BA.P.LAT 3 are made of medical-grade, sterilizable steel.” in lines 1-3. However, this language is confusing because it implies that there are other instruments. However there do not appear to be any other instruments recited in claim 2, nor in claim 1 from which claim 2 is dependent on. Please amend this to recite “where all instruments BA.P.LAT 1, BA.P.LAT 2 and BA.P.LAT 3 are made of medical-grade, sterilizable steel.”
Claim 4 lines 8-10 recites “preparing the bone for implant placement; placing the implants; positioning the nerve near the implants”. There is insufficient antecedent basis for this limitation in the claim as this limitation was not introduced prior to this recitation. To overcome this rejection, please amend this limitation to recite “preparing the bone for placement of implants” in line 8.
Claim 4 line 12 recites “stabilizing the cortical bone windows”. There is insufficient antecedent basis for this limitation in the claim as this limitation was not introduced prior to this recitation. Are these windows referring back to “a lateral bone window” recited in line 5? Please provide clarification if these elements are the same by using consistent terminology and quantity (e.g., instead of “cutting a lateral bone window”, reciting “cutting lateral cortical bone windows” in line 5). If these are unrelated limitations, please amend line 12 to recite “stabilizing cortical bone windows” to overcome this rejection.
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hassani (US 20120064484) in view of Zadeh (US 20190216568).
With respect to claim 1, Hassani teaches a set of medical instruments (at least two instruments 100, see last line of abstract below regarding separate instruments for left and right-side orientations) for facilitating nerve lateralization and transposition in oral surgeries (see abstract below), comprising: a first instrument BA.P.LAT 1 (e.g., left side orientation instrument 100, see abstract below and para. 35), a tool designed to handle, move, and lateralize the inferior alveolar nerve without tension or risk of damage (see abstract below); and, a third instrument BA.P.LAT 3 (e.g., right side orientation instrument 100), a tool used to protect the inferior alveolar nerve during surgical drill preparation and dental implant placement, thereby preventing damage to the neurovascular bundle (see abstract below and also para. 35).
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Hassani does not appear to teach a second instrument BA.P.LAT 2, a tool similar to the first instrument BA.P.LAT 1 but designed for use in a horizontal approach when necessary.
Zadeh, also drawn to dental instruments, teaches a kit of similar instruments (e.g., at least a set of three instruments- see abstract and also fig. 1-6) including an instrument (e.g., see fig. 3b, 4a, 4b) designed for use in a horizontal approach when necessary (see para. 12 and also para. 22 below) in order to permit advantageous orientation of a distal tip of the instrument at a surgical site (see para. 22 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hassani wherein the kit includes three similar instruments, including a second instrument BA.P.LAT 2, a tool similar to the first instrument BA.P.LAT 1 but designed for use in a horizontal approach when necessary, in view of Zadeh, as a matter of engineering design choice, in order to permit advantageous orientation of a distal tip of the instrument at a surgical site.
As for claim 2, Hassani, as modified by Zadeh, further teaches the set of medical instruments of claim 1, where all instruments, including the first instrument BA.P.LAT 1, the second instrument BA.P.LAT 2, and the third instrument BA.P.LAT 3 are made of medical-grade, sterilizable steel (see abstract above, para. 15, 35, 39).
As for claim 3, Hassani, as modified by Zadeh, further teaches a set of medical instruments of claim 1, wherein each instrument, including the first instrument BA.P.LAT 1, the second instrument BA.P.LAT 2, and the third instrument BA.P.LAT 3 is uniquely designed to safely mobilize the inferior alveolar nerve to a new temporary position to facilitate the placement of dental implants (see para. 44 below).
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Claim(s) 4-6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hassani (US 20120064484) and Zadeh (US 20190216568), as applied to claim 1 above, in view of Syers (US 5511565).
As for claim 4, Hassani, as modified by Zadeh, further teaches a method for facilitating nerve lateralization and transposition in oral surgeries using the set of medical instruments of claim 1 (see abstract above), the method comprising: making an incision along the lower jaw's gum line (see para. 16); creating a mucoperiosteal flap (see para. 16); cutting a lateral bone window to access the inferior alveolar nerve (see para. 16, 27); mobilizing and retracting the nerve to a lateral position using the first instrument BA.P.LAT 1 or the second instrument BA.P.LAT (see para. 27-28, 43-43); preparing the bone for implant placement (see fig. 8, para. 44); placing the implants (802- see para. 44-45); positioning the nerve near the implants, with the nerve protected by the third instrument BA.P.LAT 3 (see para. 44); and, closing the surgical site (see para. 44-45).
Hassani, as modified by Zadeh, does not appear to teach replacing and stabilizing the cortical bone windows using bone plates and screws.
Syers, also drawn to dental surgery and the associated implants, teaches replacing and stabilizing the surgical area (see col. 1 lines 16-22, col. 2 lines 56-60) using implants (52) that include bone plates (e.g., 36a) and screws (e.g., 52a) in order to close and secure the overlying soft tissue (e.g., flap) after the procedure (see col. 2 lines 1-8), as needed due to the type of procedure performed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method and implants of Hassani, as modified by Zadeh, to include replacing and stabilizing the cortical bone windows using bone plates and screws, in view of Syers, in order to close and secure the overlying soft tissue (e.g., flap) after the procedure, as needed due to the type of procedure performed.
As for claim 5, Hassani, as modified by Zadeh and Syers, further teaches the method of claim 4, wherein the first instrument BA.P.LAT 1 is used for typical access (see abstract above, fig. 4), the second instrument BA.P.LAT 2 is used for a horizontal approach (see para. 22 above of Zadeh), and the third instrument BA.P.LAT 3 is used for protection during surgical drill preparation and implant placement (see fig. 4).
As for claim 6, Hassani, as modified by Zadeh and Syers, further teaches the method of claim 4, wherein the use of the first instrument BA.P.LAT 1, the second instrument BA.P.LAT 2, and the third instrument BA.P.LAT 3 minimizes the risk of nerve damage and maximizes the space available for implant placement (see abstract above and fig. 1-8).
As for claim 8, Hassani, as modified by Zadeh and Syers, further teaches the method of claim 4, wherein the technique using the first instrument BA.P.LAT 1, the second instrument BA.P.LAT 2, and the third instrument BA.P.LAT 3 facilitates the procedure of nerve lateralization and transposition, making it more accessible and safer for a broader range of surgeons (see abstract above).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hassani (US 20120064484), Zadeh (US 20190216568) and Syers (US 5511565), as applied to claim 4 above, in view of Sabbagh (US 7938644).
As for claim 7, Hassani, as modified by Zadeh, Syers and Sabbagh, appears to be silent regarding wherein each step is performed under local anesthesia to reduce patient discomfort.
Sabbagh, also drawn to dental surgeries, teaches use of known several types anesthesia (local or general) (see col. 1 lines 13-28) in order to provide a known level of sedative depending on the procedure (see col. 1 lines 13-28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hassani, as modified by Zadeh and Syers, wherein each step is performed under local anesthesia to reduce patient discomfort, in view of Sabbagh, in order to provide a known level of sedative depending on the procedure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20170014169; US 20220346922; US 20210100637; US 9770316.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TARA ROSE E CARTER/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773