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.
Claim(s) 1-4, 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strnad et al. (Pub. No. US 2015/0257807 A1).
Regarding claims 1-4, 8-10, Strnad et al. discloses a surgical screw system (figure 16A) comprising; a screw having a body, a top end, a bottom end and an internal cavity 113i (figure 16B), a penetrating tip positioned at the bottom end (figure 16A), the penetrating tip in communication with the internal cavity (paragraph 0091); the top end having a periphery and an inset area 50i leading to the internal cavity (figure 16A), and at least one insertion tool engagement feature 112i, 60i provided on the top end, the at least one engagement feature provided on the periphery of the top end (figure 16A); and wherein the body comprises a tubular wall defining the internal cavity 113i (illustrated in figure 16A), and wherein a thickness of the tubular wall in a radial direction is smaller than an inner radius of the internal cavity (illustrated in figure 16D- the thickness of the tubular wall at the very top of the screw is smaller than an inner radius of the internal cavity 113i). The at least one tool engagement feature 60i includes a series of detents disposed around the periphery (figure 16A). The series of detents form a hexalobal feature (figure 16A). The screw system comprising at least three tool engagement features 60i, 112i, 113i (figure 16A). The at least three engagement features comprise a hexalobe feature 60i, an external hex feature 112i . The body of the screw comprises a threaded portion 82i extending radially outwardly from the body (figure 16A). The threaded portion extends substantially along a length of the body and comes to terminus before the periphery of the top end of the screw (figure 16A). The threaded portion has a diameter which reduces as the threaded portion comes to the bottom end of the body (paragraph 0042).
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Claim Rejections - 35 USC § 103
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 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) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strnad et al. (Pub. No. US 2015/0257807 A1).
Regarding claims 4 and 5, Strnad et al. discloses the claimed invention in the embodiment of figures 16A-16B, except wherein one of the three tool engagement features is an external sprocket feature.
However, in the embodiment of figures 20A and 20B, Strnad et al. teaches wherein a screw comprises a plurality of tool engagement features, one of which is an external sprocket feature 117n (figures 20A and 20B; paragraph 0119), for the purpose of providing a fastener which can accommodate a variety of driving tools, and potentially simplify the tool requirements for a user of the system (paragraph 0119).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the screw disclosed in the embodiment of figures 16A-16B of Strnad et al. to comprise a third tool engagement feature which is an external sprocket feature, as taught in the embodiment of figures 20A and 20B or Strnad et al., in order to provide a fastener which can accommodate a variety of driving tools, and potentially simplify the tool requirements for a user of the system (paragraph 0119).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strnad et al. (Pub. No. US 2015/0257807 A1) in view of Myers (Pub. No. US 2017/0303981 A1).
Regarding claim 6, Strnad et al. discloses the claimed invention except wherein the system further comprises a hook, wherein the internal cavity comprises a groove for receipt of the hook as a means to remove the screw.
Myers teaches a screw system comprising a hook 27, wherein the internal cavity comprises a groove 54 for receipt of the hook as a means to remove the screw (figures 3 and 5), for the purpose of temporarily locking the driver to the screw (paragraph 0043-0044).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the system to further comprise a hook, wherein the internal cavity comprises a groove for receipt of the hook as a means to remove the screw, as taught by Myers, for the purpose of temporarily locking the driver to the screw (paragraph 0043-0044).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strnad et al. (Pub. No. US 2015/0257807 A1) in view of Asfora (Pub. No. US 2014/0046382).
Regarding claim 7, Strnad et al. teaches wherein the screw can be manufactured from titanium (paragraph 0126), but fails to disclose wherein the implant is manufactured from Ti-6A1-4V ELI.
However, Asfora teaches wherein a bone implant is manufactured from Ti-6A1-4V ELI in order to provide an implant that is corrosion resistant and biocompatible (paragraph 0031).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed for the screw to be manufactured from Ti-6A1-4V ELI as taught by Asfora, in order to provide an implant that is corrosion resistant and biocompatible (paragraph 0031).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strnad et al. (Pub. No. US 2015/0257807 A1) in view of Luks et al. (Pat. No. US 6,368,322 B1).
Regarding claim 18, Strnad et al. discloses a multiple drive interference screw device comprising: a screw comprised of a body, a first end and a second end, wherein the first and second ends are disposed at opposite ends of the body (figures 16A and 16B); a cavity 113i within the body and extending between the first end and second end (figures 16A and 16B; paragraph 0091); a penetrating tip disposed at the second end of the screw (figure 16A); and at least three tool engagement features 60i, 112i, 113i disposed at the first end of the screw (figure 16A), wherein the at least three engagement features comprise a lumen 113i, and external hex feature 112i, and an external sprocket feature 60i (figure 16A); and wherein the at least three engagement features are layered within each other with the external hex feature 112i positioned around a major diameter of the first end (figures 16A-16D), the lumen feature 113i positioned within the external hex feature, and the external sprocket feature 16i positioned exterior to the external hex feature 112i (figures 16A-16D).
Strnad et al. discloses the claimed invention except wherein the lumen feature 113i is a hexalobe feature. Strnad et al. discloses that the lumen 113i can have various shapes, but does not specify a hexalobe shape.
Luks et al. teaches wherein an internal lumen 22 comprises a hex shape, among other shapes, for the purpose of engaging with an insertion tool to produce torque (col. 3, line 66-col. 4, line 16; figures 1 and 4).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the lumen disclosed by Strnad et al. to comprise a hex shape, as taught by Luks et al., for the purpose of engaging with an insertion tool to produce torque if one so desires.
It would have been further obvious for the shape to be a hexalobe shape, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person having ordinary skill in the art would find obvious for the purpose of providing a tool engaging lumen in a screw. In re Dailey and Eilers, 149 USPQ 47 (1966).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strnad et al. (Pub. No. US 2015/0257807 A1) in view of Luks et al. (Pat. No. US 6,368,322 B1) and further in view of Myers (Pub. No. US 2017/0303981 A1).
Regarding claim 20, Strnad et al. as modified by Luks discloses the claimed invention except wherein the system further comprises a removal tool, wherein the internal cavity comprises a groove for use of the removal tool, and the removal tool is one of a hook, a grapple, or a crook.
Myers teaches a screw system comprising a removal tool 10, wherein the internal cavity comprises a groove 54 for use of the removal tool, and the removal tool is one of a hook, a grapple, or a crook (figures 3 and 5), for the purpose of providing a tool which can be connected with an hold the screw (paragraph 0043-0044).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the system to further comprise a hook, wherein the internal cavity comprises a groove for receipt of the hook as a means to remove the screw, as taught by Myers, for the purpose of providing a tool which can be connected with an hold the screw (paragraph 0043-0044).
Response to Arguments
Applicant's arguments filed 9/29/2025 have been fully considered but they are not persuasive.
With regard to claims 1-10, Applicant’s arguments are not persuasive. As illustrated in figure 16D, the tubular wall which defines the internal cavity has a thickness which is smaller than the radius of the internal cavity.
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Applicant’s arguments with respect to claim(s) 18 and 20 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. Strnad is interpreted in a new manner in combination with Luks to teach the claimed limitations.
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 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 Lynnsy Summitt whose telephone number is (571)270-78567856. The examiner can normally be reached on Monday through Thursday from 8am until 5pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, 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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/LYNNSY M SUMMITT/Primary Examiner, Art Unit 3773