CTNF 19/072,404 CTNF 84592 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. This is the initial Office action for the 19/072,404 application. Claims 1-3 are pending. Claims 1-3 are directed to the implant embodiment illustrated in Figs. 15A-15C which is disclosed as “having a design that allows for the implant to be inserted in an orientation that is rotated ninety degrees from the traditional insertion orientation of such an implant.” Claim 1 includes the recitation that “the insertion tool is removably attachable to the implant and adapted to insert the implant between adjacent vertebrae in a first orientation with the first and second side walls configured to contact the adjacent vertebrae and rotating the implant 90 degrees to a second orientation with the superior and inferior surfaces configured to contact the adjacent vertebrae.” Priority 02-09 AIA Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 121 as follows: 02-10 AIA The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc. , 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, Application No. 17/225,393 , fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claim 1 includes the recitation of “an insertion tool having first and second arms configured to contact first and second chamfered edges.” The ‘393 lacks any reference to an insertion tool comprising first and second arms. The only illustration of an insertion tool is provided in Fig. 10 which merely illustrates a rectangle 60 . Accordingly, the effective filing date for the claimed subject matter in the current application is March 6, 2025 and will be treated as such for examination purposes . Specification 07-44 AIA The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification must detail an insertion tool having first and second arms configured to contact the first and second chamfered edges . Drawings 06-36 AIA 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 first and second arms of the insertion tool 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 07-30-02 AIA 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. 07-34-01 Claims 1-3 are 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 recites “an insertion tool having first and second arms configured to contact first and second chamfered edges.” It is noted that the Specification and Drawings lack any references or figures including an insertion tool having first and second arms. The only detail of an insertion tool that is disclosed is a rectangular box included in Fig. 10, element 60. Structural connection details between the inserter and implant are lacking and therefore claims 1-3 fail to particularly point out and distinctly claim the invention. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim (s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Willis et al. (U.S. 2016/0199193 A1) in view of Trudeau (CA 3 074 834) . Willis et al. disclose a spinal implant system (see Figs. 15A-15C) comprising: a spinal implant having an elongate body having: a central longitudinal axis extending through the body; a front section and a rear section, the rear section having a rear wall and an internally threaded opening; an upper surface extending between the front section and the rear section; a lower surface extending between the front section and the rear section; a first side wall extending between the upper surface and the lower surface on a first side of the longitudinal axis; and a second side wall extending between the upper surface and the lower surface on a second side of the longitudinal axis, the first side wall and the second side wall comprising a first recess and a second recess, respectively, wherein an intersection of the first side wall and the upper surface comprises a first chamfered edge and wherein an intersection of the second side wall and the lower surface comprises a second chamfered edge, wherein the rear wall is generally perpendicular to the first side wall and the second side wall; and an insertion tool, wherein the insertion tool is removably attachable to the implant and adapted to insert the implant between adjacent vertebrae in a first orientation with the first and second side walls configured to contact the adjacent vertebrae and rotating the implant 90° to a second orientation with the superior and inferior surfaces configured to contact the adjacent vertebrae. Concerning claim 2, wherein the body includes porous and non-porous sections, one or more non-porous struts extending through the porous section from the first side wall to the second side wall. Concerning claim 3, wherein at least one of the non-porous struts extends beyond any of the upper or lower surfaces. However, Willis et al. do not disclose that the insertion tool has first and second arms configured to contact the first and second chamfered edges. Trudeau discloses a spinal implant system including an insertion tool (see Fig. 39) having first and second arms configured to contact first and second chamfered edges of an implant for insertion between vertebrae. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Willis’ system to includes an insertion tool having first and second arms configured to contact first and second chamfered edges of the implant, as taught by Trudeau, in order to precisely place the implant in a confined, sensitive surgical space. An inserter with clamping arms is a straightforward mechanical solution to a clear problem: the need for firm gripping, accurate insertion, and release without disruption to adjacent structures. The general concept of a tool with clamping/gripping arms to hold and place a component is ubiquitous in surgical instrumentation. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM . If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at 571 272-4719 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ELLEN C HAMMOND/Primary Examiner, Art Unit 3773 Application/Control Number: 19/072,404 Page 2 Art Unit: 3773 Application/Control Number: 19/072,404 Page 3 Art Unit: 3773 Application/Control Number: 19/072,404 Page 4 Art Unit: 3773 Application/Control Number: 19/072,404 Page 5 Art Unit: 3773 Application/Control Number: 19/072,404 Page 6 Art Unit: 3773 Application/Control Number: 19/072,404 Page 7 Art Unit: 3773
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