Detailed Action
This is the final office action for US application number 18/515,470. Claims are evaluated as filed on December 8, 2025.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre- AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed December 8, 2025 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims as detailed below.
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 “the implant comprises a circular cross-section” of claim 17 lines 1-2 must be shown or the feature(s) canceled from the claim(s). 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 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(s) 6 and 9-19 is/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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claims 6 and 9-19, “the distal end surface comprises a first planar surface defined by a plane transverse to the longitudinal axis” in claim 6 lines 9-10 appears to be new matter. That is, the specification is silent to such a disclosure, the drawings do not include a scale or indicator that would allow such a determination, and such was not originally claimed. Thus, “the distal end surface comprises a first planar surface defined by a plane transverse to the longitudinal axis” in claim 6 lines 9-10 constitutes new matter. Examiner suggests amending as “the distal end surface comprises a first generally planar surface defined generally planar surface seats securely” in claim 6 line 30.
As to claims 6 and 9-19, “the intermediate surface comprises a second planar surface defined by a plane transverse to the longitudinal axis” in claim 6 lines 26-28 appears to be new matter. That is, the specification is silent to such a disclosure, the drawings do not include a scale or indicator that would allow such a determination, and such was not originally claimed. Thus, “the intermediate surface comprises a second planar surface defined by a plane transverse to the longitudinal axis” in claim 6 lines 26-28 constitutes new matter. Examiner suggests amending as “the intermediate surface comprises a second generally planar surface defined generally planar surface seats securely” in claim 6 line 32.
As to claim 9, the implant comprises “a non-circular transverse profile” of claim 9 lines 2-3 appears to be new matter. This is a negative limitation, i.e. the claim is requiring that the transverse profile is not circular. Negative limitations are not per se improper, but they must be supported by the originally filed disclosure. As provided by MPEP 2173.05(i), any negative limitation or exclusionary proviso must have basis in the original disclosure; if alternative elements are positively recited in the specification, they may be explicitly excluded in the claims; and the mere absence of a positive recitation is not basis for an exclusion. The specification is silent regarding the transverse profile not being circular. As noted above, the absence of a positive recitation is not a proper basis of support for a negative limitation. Additionally, since the specification is silent on the matter of the transverse profile being circular, then the “alternative elements” rationale discussed above in the MPEP is not applicable. Thus, the implant comprises “a non-circular transverse profile” of claim 9 lines 2-3 constitutes new matter. Examiner suggests cancelling this limitation or amending to language supported by Fig. 10.
As to claim 10, the bore comprises “a non-circular transverse profile” of claim 10 line 3 appears to be new matter. This is a negative limitation, i.e. the claim is requiring that the transverse profile is not circular. Negative limitations are not per se improper, but they must be supported by the originally filed disclosure. As provided by MPEP 2173.05(i), any negative limitation or exclusionary proviso must have basis in the original disclosure; if alternative elements are positively recited in the specification, they may be explicitly excluded in the claims; and the mere absence of a positive recitation is not basis for an exclusion. The specification is silent regarding the transverse profile not being circular. As noted above, the absence of a positive recitation is not a proper basis of support for a negative limitation. Additionally, since the specification is silent on the matter of the transverse profile being circular, then the “alternative elements” rationale discussed above in the MPEP is not applicable. Thus, the bore comprises “a non-circular transverse profile” of claim 10 line 3 constitutes new matter. Examiner suggests cancelling this limitation or amending to language supported by Figs. 7E and 7F.
Allowable Subject Matter
Claim 7 is allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775