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 .
Election/Restriction
Applicant’s election of group II, claims 16-22, in the Non-Final rejection mailed 12/17/2025 is acknowledged. Because applicant has not distinctly and specifically pointed out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group I, there being no allowable generic or linking claim.
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.
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.
Claim(s) 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al., U.S. PG-Pub 2003/0158555 in view of Humphreys et al., U.S. PG-Pub 2014/0066945 (previously sited in the PTO-892 dated 12/17/2025).
Regarding claim 16, Sanders et al. discloses a bone screw for compressing adjacent bones across a bone fusion site, comprising: a head portion (6) comprising a superior end and an inferior end; wherein the inferior end is configured to be received within a slanted aperture, such that a majority of the head portion countersinks within the slanted aperture; a shaped opening (3) disposed within the superior end and configured to engagedly receive a tool for driving the bone screw into a hole drilled across the fusion site; a shank (2) extending from the inferior end, the shank comprising distal threads (5) and a proximal smooth portion; and a distal end configured to be advanced within the hole (examiner annotated Fig. 1a below).
PNG
media_image1.png
526
292
media_image1.png
Greyscale
Sanders et al. discloses the shaped opening (3) being comprised of trilobe shape (Fig. 1d), but does not disclose the shaped opening being comprised of a hexalobe shape.
Humphreys et al. discloses a bone screw having a head portion with a hexalobe (68) shape (Fig. 4) for providing driving torque to the screw (paragraph [0020]), and wherein there may be any number of lobes (paragraph [0037]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shaped opening of Sanders et al. to be hexalobe shaped in view of Humphreys et al. as such provides a functionally equivalent means for providing driving torque to the head portion of the screw.
Regarding claim 17, Sanders et al. discloses wherein the shaped opening (3) is substantially concentric with a longitudinal axis of the shank and comprises a multi-lobe shape suitable to receive the tool (examiner annotated Figs. 1a and 1d below).
PNG
media_image2.png
688
403
media_image2.png
Greyscale
Regarding claims 18 and 19, Sanders et al. discloses wherein the inferior end is configured to be received within a slanted aperture of a bone plate, such that the head portion countersinks within the slanted aperture and presses the bone plate against a surface of the adjacent bones; and wherein a maximal circumference of the head portion (6) is disposed between the superior end and the inferior end so as to minimize protrusion of the head portion above an upper surface of the bone plate (examiner annotated fig. 1a below).
PNG
media_image3.png
481
386
media_image3.png
Greyscale
Regarding claim 20, Sanders et al. discloses wherein the distal threads (5) are configured to rotatably engage within the hole, and wherein the proximal smooth portion is configured to pass through the bone with relatively little resistance, the smooth portion being configured to allow the bone fusion site to close as the adjacent bones are compressed together (examiner annotated Fig. 1a under the rejection of claim 16 above).
Claim(s) 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al., U.S. PG-Pub 2003/0158555 in view of Humphreys et al., U.S. PG-Pub 2014/0066945 as applied above, and further in view of Mobasser, U.S. PG-Pub 2012/0136398.
Regarding claims 21 and 22, Sanders et al. in view of Humphreys et al. discloses the invention essentially as claimed except for wherein the distal end includes one or more shapes/flutes that spiral along a portion of the distal threads and are configured to minimize resistance to forward movement of the bone screw within the hole drilled in the adjacent bones and are configured to clean an interior of the hole and remove bone debris therefrom.
Mobasser discloses a bone screw having threads (200) with one or more flutes (180) that spiral along a portion of the threads (Fig. 3) for conveying bone material away from the tip of the screw during insertion of the screw into bone and for removing bone material (paragraph [0014]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distal end of Sanders et al. to includes one or more shapes/flutes that spiral along a portion of the distal threads and are configured to minimize resistance to forward movement of the bone screw within the hole drilled in the adjacent bones and are configured to clean an interior of the hole and remove bone debris therefrom further in view of Mobasser to permit conveying bone material away from the distal end of the screw during insertion of the screw into the bones and to permit removal of bone material.
Response to Arguments
Applicant’s arguments, see Remarks, filed 20 April 2026, with respect to the objection of claim 19 and the rejection of claims 18 and 19 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The objection of claim 19 and the rejection of claims 18 and 19 under 35 U.S.C. 112(b) have been withdrawn.
Applicant's arguments filed 20 April 2026, regarding claim 16, have been fully considered but they are not persuasive. Applicant contends Sanders et al. fails to teach or suggest a head portion comprising a superior end and an inferior end, wherein the inferior end is configured to be received within a slanted aperture, such that a majority of the head portion countersinks within the slanted aperture.
In response to applicant’s argument that Sander’s et al. does not teach or suggest a head portion comprising a superior end and an inferior end, Sanders et al. does teach a head portion (6) having a superior end and an inferior end as can be seen in examiner annotated Fig. 1a below the rejection of claim 16 above.
In response to applicant's argument that Sanders et al. does not teach or suggest the inferior end is configured to be received within a slanted aperture, such that a majority of the head portion countersinks within the slanted aperture, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the inferior end of head portion (6) is fully capable of being received within a slanted aperture such that a majority of the head portion countersinks within the slanted aperture.
Applicant’s arguments, see Remarks, filed 20 April 2026, with respect to the rejection(s) of claim(s) 16 under 35 U.S.C. 102(a)(1) and 102(a)(2), regarding the shaped opening being comprised of a hexalobe shape have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made to Sanders et al., U.S. PG-Pub 2003/0158555 in view of Humphreys et al., U.S. PG-Pub 2014/0066945.
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 Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571) 272-4705. 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.
/ERIC S GIBSON/ Primary Examiner, Art Unit 3775
Prosecution Insights