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 .
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 9-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trieu (US Publication No. 2012/0191191 A1).
Regarding Claim 9, Trieu discloses an implant (20) comprising:
an outer cage (50) (“sleeve 50 may have a porous or cage configuration”, [0036]) and an internal screw (22+72) aligned along a central longitudinal axis (shown in Fig. 2), the outer cage (50) having a polygonal outer shape configured to limit rotational motion (Fig. 9, [0055]), and
the internal screw (22+72) is sized and dimensioned to fit through the outer cage (50), the internal screw (22+72) having an enlarged head (72) and a shaft (40) with one or more threaded sections (34, 46, Fig. 2),
wherein the outer cage (50) is free to rotate relative to the internal screw (22) (screw is screwed down into bore of cage during which there is free rotation- the screw can rotate clockwise or counterclockwise relative to the cage), and
wherein at least one of the threaded sections (at 46) is positioned within the outer cage (50) when the internal screw (22) is positioned through the outer cage (described in [0037] and shown in Fig. 2 as the surface 46 of screw can have threaded surface to engage with surface 62 of cage 50).
Regarding Claim 10-11, the outer cage (50) has a triangular cross- section which includes three faces and three vertices (Fig. 9) [0055].
Claim(s) 9, 12-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Knothe et al. (US Patent No. 588228 A1).
Regarding Claim 9, Knothe discloses an implant (Fig. 8) comprising:
an outer cage (1) and an internal screw (2) aligned along a central longitudinal axis (shown in Fig. 8), the outer cage (1) having a polygonal outer shape configured to limit rotational motion (rectangular), and
the internal screw (2) is sized and dimensioned to fit through the outer cage (1) (Fig. 8), the internal screw (2) having an enlarged head (proximal end of tapered screw is larger than any other part) and a shaft (remaining length of screw) with one or more threaded sections (21, Fig. 7),
wherein the outer cage (1) is free to rotate relative to the internal screw (2) (“circular-cylindrical rotation element 2 is rotatably mounted in the cage 1”, col. 2; ln. 58-59), and
wherein at least one of the threaded sections (21) is positioned within the outer cage (1) when the internal screw (2) is positioned through the outer cage (Fig. 8).
Regarding Claim 12 and 13, the shaft of the internal screw includes one or more narrowed shaft portions (25, Fig. 7 and can also be seen in view of Fig. 6), and the outer cage defines corresponding narrowed sections (26) configured to mate with the narrowed shaft portions, wherein the narrowed shaft portions act as stops to prevent the outer cage from translating along the central longitudinal axis and, wherein the narrowed shaft portions are non- threaded and have a reduced diameter relative to the threaded sections (Fig. 6-8, col. 2; ln. 58-65).
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) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trieu (US Publication No. 2012/0191191 A1) in view of in view of Reiley et al. (US Publication No. 2016/0081810 A1)
Trieu discloses the implant of claim 9 as described above, however is silent to one or more prongs extending distally from the outer cage.
Reiley discloses an sacroiliac joint implant in the same field of endeavor wherein a triangular cage which is inserted into the joint has ribs 24 (prongs) which can extend from the distal end of the cage [“In other embodiments, the ribs 24 can extend from the distal ends of the elongate body 12”, 0070] in order to contact the bone in situations where a previous implant is being replaced [0069-0070]. It would have been obvious to one having ordinary skill in the art to modify the triangular cage of Trieu to include ribs/prongs extending from the distal end thereof in order to engage bone in situations where the implant is being used in revision surgery.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trieu (US Publication No. 2012/0191191 A1) in view of Lewis et al. (US Publication No. 2022/0354654 A1).
Trieu discloses the implant of claim 9 as described above, however is silent the implant includes a spiral sweep interrupting the threaded sections and the sweep includes a lattice structure.
Lewis discloses a sacroiliac joint fusion implant in the same field of endeavor. Lewis disclose that the threads of the screw portion of the implant have a spiral sweep (spiral cutting flutes 12) interrupting them and the flutes/sweep has windows (14) therein (considered to form a lattice structure) in order to harvest the bone chips as the screw is being advanced [0008, 0047].
It would have been obvious to one having ordinary skill in the art to modify the threaded sections of the implant of Trieu to have interrupting spiral sweep/cutting flutes with lattice structure/bone harvesting windows therein extending along the length of the implant as taught by Lewis in order to remove the bone chips from interfering with the threads as well as provide an osseointegration medium within the screw to facilitate bone ingrowth.
Response to Arguments
Applicant’s arguments with respect to claim(s) 9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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 JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
