DETAILED ACTION
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2 and 4-8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kraus et al. (US 20060190081 A1) in view of Pavlov et al. (US 5906616) further in view of Tallarida et al. (US 20020055783).
Regarding claim 2, Kraus et al. disclose insertion of a fusion cage or facet implant 30 sized and shaped for placement into interfacet space 18 utilizing a minimally invasive surgical technique (Fig. 3A, para [0033] and para [0034]) wherein the body of implant 30 is threaded and a first surface portion of implant 30 engages a superior articulating surface and a second surface portion of implant 30 engages an inferior articulating surface (Fig. 3A, paras [0005], [0033]-[0034] and [0038]).
Regarding claim 5, implant 30 is constructed of titanium (para [0037]).
Regarding claim 8, implant 30 can be inserted into any facet joint at any level of the spine depending on a patient’s condition (Fig. 3A shows a facet joint).
Kraus et al. disclose all elements of the claimed invention except for: (1) a guide tool; (2) a proximal portion of the implant to have a recess for removably engaging a distal portion of a delivery tool or driver (claim 4); (3) the proximal portion of implant 30 to have a first diameter that is greater than a second diameter of a distal portion of the implant (claim 6); and (4) the distal end of the implant to have a smaller profile than a proximal end of the implant (claim 7).
Pavlov et al. disclose utilizing a posterior approach and procedure to obtain access to adjacent vertebral structures wherein the procedure is performed in a minimally invasive manner through a set of cannula (any one cannula being a guide tool) and an insertion or driver tool 62 with a distal portion having a male drive feature 74 that releasably engages a bore or recess 34 of a threaded implant 20 for placement of the implant between adjacent vertebral bodies (e.g. Figs. 1-2, 5, 7-9, col. 4, lines 49-67, col. 5 and col. 6, lines 1-51).
Therefore, it would have been recognized by one of ordinary skill in the art that applying the known technique of inserting a threaded implant between adjacent vertebral bodies in a minimally invasive manner utilizing a posterior approach and the technique of implant delivery, as taught by Pavlov et al., to place the Kraus et al. implant, would have yielded the predictable result of ease of placement of the threaded Kraus et al. implant into bone while minimizing trauma to a patient.
Regarding claims 6 and 7, Pavlov et al. disclose the proximal portion of the implant to be wider than a distal portion of the implant to provide a conical shape to the implant to facilitate insertion (Fig. 1 and col. 4, lines 49-67, col. 5 and col. 6, lines 1-51).
Therefore, it would have been recognized by one of ordinary skill in the art that applying the known technique of providing an implant with a conical shape wherein the proximal portion has a diameter larger than a diameter of a distal portion, would have yielded predictable results, i.e., ease of insertion of the implant.
The combination of Kraus et al. and Pavlov et al. disclose all elements of the claimed invention except for a plurality of interruptions in the thread along a longitudinal axis of the implant.
It is well known to provide interruptions in the thread portion of an implant to prevent migration or rotational movement of the screw, as evidenced by Tallarida et al. (para [0098]).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique of providing milled slots in the thread of the implant in the system of the combination of Kraus et al. and Pavlov et al., as evidenced by Tallarida et al., to inhibit migration and rotational movement of the implant.
Response to Arguments
Applicant’s arguments have been fully considered but are not found to be persuasive. Upon consideration of Applicant’s arguments, the rejections under 35 USC 103(a) over Mickiewicz et al. in view of Tallarida et al. are being withdrawn by the Examiner. Regarding the rejections under 35 USC 103(a) over Kraus et al. in view of Pavlov et al. further in view of Tallarida et al., Applicant’s arguments regarding Pavlov et al. and Tallarida et al. are not found to be persuasive for the following reasons. Pavlov et al. is relevant to Applicant’s invention because it is related to implant insertion and features that facilitate implant insertion. Tallarida et al. is also relevant to Applicant’s invention because it discloses providing interruptions in threads on an externally threaded implant to prevent migration and rotational movement of the implant. The test for obviousness is what the combined teachings of the references would have suggested to those of ordinary skill in the art (MPEP 2145 (IV)).
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
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April 2, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775