DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I (insertion device claims 1-11) and Species B (Fig. 13) in the reply filed on March 9, 2026 is acknowledged.
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 16-18 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 16 becomes confusing when it mentions the inner shaft has an inner lumen that couples to a feature on the main body of the implant. Looking at Figs. 13-15 and specifically Fig. 15, the inner shaft 144 has an inner lumen 142, but this lumen is not coupling to any feature of the implant 210. It seems the outer surface of the inner shaft is what connects to the implant. Claims 17-18 are dependent off claim 16.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1, 11, and 14 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Sasso et al. (US 2004/0225292; “Sasso”).
Claim 1, Sasso discloses an insertion device (Fig. 9) for implanting a fusion implant across a sacroiliac joint (Fig. 9), the fusion implant having a coupling head and a main body extending distally from the coupling head (Fig. 9), comprising: an inner shaft (352) having a proximal end (upper end) and a distal end (end that 342b points towards), the inner shaft having a counter-rotation feature (Fig. 8; 351) capable of releasably coupling to a corresponding feature formed on the main body of the fusion implant so as to prevent the inner shaft from rotating relative to the fusion implant (Fig. 9) and to allow the distal end of the inner shaft to pass through the coupling head and enter the main body (Fig. 9); an outer shaft (400) having a proximal end (upper end) and a distal end (where 404 points) and coupled to the inner shaft such that the inner shaft can rotate and travel along a longitudinal axis of the insertion device independently of the outer shaft (Fig. 9; paragraphs [0060]-[0062]), wherein the distal end of the outer shaft has an external threading (Fig. 9; 405) configured to threadingly couple to an internal threading formed on the coupling head of the fusion implant (Fig. 9).
Claim 11, Sasso discloses the insertion device of claim 1, wherein the outer shaft comprises a guide lumen (Fig. 9; 402) configured to form a sliding fit over the inner shaft (paragraph [0060]).
Claim 14, Sasso discloses the insertion device of claim 1, wherein the counter-rotation feature includes a multi-sided tip (there are top and bottom sides to the threads and the cylinder could be broken into left, right, front and back sides).
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) 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 16 and 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sasso et al. (US 2004/0225292; “Sasso”).
Claim 16, Sasso discloses an insertion device (Fig. 9; 400) for implanting a fusion implant across a sacroiliac joint, the fusion implant having a coupling head and a main body extending distally from the coupling head (Fig. 9), the insertion device comprising: an inner shaft (Fig. 8; 314) having a proximal end (upper end) and a distal end (end that 350 points towards), the inner shaft including an distal end (350) having an anti-rotation feature (351) configured to releasably and slidably couple to a corresponding feature formed on the main body of the fusion implant so as to prevent the inner shaft from rotating relative to the fusion implant and to allow the distal end of the inner shaft to pass through the coupling head and enter the main body (Figs. 8-9; paragraphs [0059]-[0063]); an outer shaft (Fig. 9; 405) having a proximal end (upper end) and a distal end (end that 405 points towards), and slidably coupled to the inner shaft such that the inner shaft can rotate and travel along a longitudinal axis of the outer shaft independently of the outer shaft (Fig. 9; paragraphs [0059]-[0063]), wherein the distal end includes threading (Fig. 9; 405) configured to threadingly couple to threading formed on the coupling head of the fusion implant (Fig. 9).
However, in the embodiment shown in Fig. 9, the inner shaft does not include an inner lumen.
In alternate embodiments, the inner shaft includes an inner lumen (Figs. 2, 6, and 7; 54, 154, 254) configured to allow fusion material to be pushed therethrough (Figs. 2, 6, and 7; paragraph [0035]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include an inner lumen to the inner shaft, since it is the same device performing the same function of guiding other tools to the screw (paragraph [0060]) and the lumen would allow for material to be inserted therethrough (paragraph [0035]).
Claim 17, Sasso discloses the insertion device of claim 16, wherein the anti-rotation feature includes a multi-sided tip (there are top and bottom sides to the threads and the cylinder could be broken into left, right, front and back sides).
Claims 14-15 and 17-18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sasso et al. (US 2004/0225292; “Sasso”), in view of Neff (US 2005/0277940).
Claim 14, Sasso discloses the insertion device of claim 1.
While Sasso teaches the claim language, it is not the same structure shown in Applicant’s device.
Neff teaches a counter-rotation feature within a screw shank (Fig. 1; 27) that includes a multi-sided tip (Fig. 1; 27).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the threaded distal tip of the inner shaft to be a polygonal sided tip, as taught by Neff, since this is a common drive feature between screws and drivers (Figs 1 and 4; paragraph [0023]).
Claim 15, Sasso discloses the insertion device of claim 1.
However, Sasso does not disclose the octagon-shaped tip.
Neff teaches a counter-rotation feature within a screw shank (Fig. 1; 27) that includes a multi-sided tip (Fig. 1; 27).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the threaded distal tip of the inner shaft to be a polygonal sided tip, as taught by Neff, since this is a common drive feature between screws and drivers (Figs 1 and 4; paragraph [0023]).
While the tip is not necessarily an octagon, they contemplate different styles, shapes, and number of sides (paragraph [0023]) and Applicant mentions how any number and size may be used (paragraph [0059]), therefore, it would have been obvious to one of ordinary skill in the art to make the tip with eight sides, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of helping create a torque driving feature.
Claim 17, Sasso discloses the insertion device of claim 16.
While Sasso teaches the claim language, it is not the same structure shown in Applicant’s device.
Neff teaches a counter-rotation feature within a screw shank (Fig. 1; 27) that includes a multi-sided tip (Fig. 1; 27).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the threaded distal tip of the inner shaft to be a polygonal sided tip, as taught by Neff, since this is a common drive feature between screws and drivers (Figs 1 and 4; paragraph [0023]).
Claim 18, Sasso discloses the insertion device of claim 16.
However, Sasso does not disclose the octagon-shaped tip.
Neff teaches a counter-rotation feature within a screw shank (Fig. 1; 27) that includes a multi-sided tip (Fig. 1; 27).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the threaded distal tip of the inner shaft to be a polygonal sided tip, as taught by Neff, since this is a common drive feature between screws and drivers (Figs 1 and 4; paragraph [0023]).
While the tip is not necessarily an octagon, they contemplate different styles, shapes, and number of sides (paragraph [0023]) and Applicant mentions how any number and size may be used (paragraph [0059]), therefore, it would have been obvious to one of ordinary skill in the art to make the tip with eight sides, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of helping create a torque driving feature.
Response to Arguments
In response to Applicant’s arguments towards the amendments of claim 1. It still appears that Sasso reads on the claim. Initially it should be noted that the implant is not positively recited. Therefore, even though Sasso shows the inner shaft engaging with the neck region of the screw/implant, for the sake of the rejection and what the claims require, the prior art only needs to show the insertion device capable of engaging such a screw/implant. Therefore a different screw that had threads further down in the shaft of the implant could be used, so imagine what is shown in Fig. 8 of Sasso but the lower inner thread 342a could be slid down a little bit or the head could be shrunk. Regardless, the head portion of Sasso could be considered to only extend to the bottom of upper inner threads 343b and the main body can be considered to start at the lower inner threads 342a.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Some of the newly cited art teach different driving mechanisms that slide further into the shaft of the screw.
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 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 Zade Coley whose telephone number is (571)270-1931. The examiner can normally be reached M-F (9-5) PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at (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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/Zade Coley/Primary Examiner, Art Unit 3775
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