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 .
EXAMINER’S AMENDMENT
The following change to the claim has been approved and agreed upon by applicant (Attorney of record: HARRY AHN) via phone call on 04/30/2026:
21. (New) The fastener of claim 1, wherein each thread section has at least five
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)(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.
Claims 1, 3-8, 10-11, 13-18 and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hyer et al., US20220249148 (hereinafter, Hyer).
Regarding claim 1, Hyer discloses an orthopedic bone fastener (see Figs. 1-2) comprising:
a screw head 104 and a shaft 105 extending along a central longitudinal axis 103 between a proximal end 101 and a distal end 102, the screw head defining a drive recess (see Fig. 1D) and the shaft configured for engaging bone (see Abstract); and
an external thread 120 helically wound around the shaft, each thread section having a crest (C, as indicated in annotated Fig. 1D), a root (R, as indicated in annotated Fig. 1D), and leading (LF, as indicated in annotated Fig. 1D) and following flanks (FF, as indicated in annotated Fig. 1D) connecting the crest to adjacent roots, wherein the leading flank faces toward the distal end (see Fig. 1D) and is configured to enter into bone first and the following flank faces toward the proximal end of the bone fastener (see Fig. 1D), and wherein at least one of the leading and following flanks comprises an undercut 132, thereby forming a hooked thread profile (see Fig. 1D),
wherein the undercut is a concave recessed surface (see para. [0067]) with a radius of curvature extending between the crest and the root (see Fig. 1D and as a reference in Fig. 3).
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Annotated Fig. 1D
Regarding claim 3, Hyer discloses the fastener of claim 1, wherein the undercut is a radial undercut (see Fig. 1D and as a reference in Fig. 3).
Regarding claim 4, Hyer discloses the fastener of claim 1, wherein the hooked thread profile extends along an entire length of the shaft (see Figs. 1C-2B).
Regarding claim 5, Hyer discloses the fastener of claim 1, wherein the distal end of the bone fastener includes a relief cut (RC, as indicated in annotated Fig. 1D) configured to preserve bone upon entry of the bone fastener.
Regarding claim 6, Hyer discloses the fastener of claim 1, wherein the crest is convexly curved (see Fig. 1D and as a reference Fig. 3).
Regarding claim 7, Hyer discloses the fastener of claim 1, wherein the external thread includes a dual lead thread (see threads 110 and 120 in Figs. 1C-1D) including a dual radial undercut (132 and 112 in Fig. 1D).
Regarding claim 8, Hyer discloses an orthopedic bone fastener (see Fig. 1C-1D) configured for lagging bone fragments together comprising:
a screw head 104 and a shaft 105 extending along a central longitudinal axis 103 between a proximal end 101 and a distal end 102; and
a dual lead thread 110, 120 helically wound around the shaft including a first thread section 110 and a second thread section 120, each thread section having a crest (see tip of the threads in Fig. 1D), a root (see roots between the threads in Fig. 1D), and leading and following flanks (see concave and convex sides of each thread in Fig. 1D) connecting the crest to adjacent roots, wherein the leading flank faces toward the distal end (see concave side of the threads facing towards the distal end 102) and is configured to enter into bone first and the following flank faces toward the proximal end of the bone fastener (see convex side of the thread facing towards the head of the fastener), and wherein each of the first and second thread sections comprise an undercut 112, 126 having a curved surface (see Fig. 1D), thereby forming a hook-like thread configured to help resist axial and lateral motions (see Fig. 1D).
Regarding claim 10, Hyer discloses the fastener of claim 8, wherein the first and second thread sections comprise dual radial undercuts facing toward one another (see annotated Fig. 1D showing first and second thread sections comprise dual radial undercuts facing one another indicated inside the circle).
Regarding claim 11, Hyer discloses the fastener of claim 8, wherein an area between the first thread section and the second thread section forms a U-shaped groove (see circled portion in annotated Fig. 1D showing U-shaped groove between the first thread section 110 and the second thread section 120).
Regarding claim 13, Hyer discloses the fastener of claim 8, wherein the first thread section 110 includes an angled leading flank (see slightly bent/angled leading flank in Fig. 1D) and a first undercut (see circled section of Fig. 1D) on the following flank.
Regarding claim 14, Hyer discloses the fastener of claim 13, wherein the second thread section 120 includes a second undercut (see circled portion of Fig. 1D) on the leading flank and an angled following flank (see slightly bent or angled flank in Fig. 1D).
Regarding claim 15, Hyer discloses an orthopedic bone fastener (see Fig. 1C-1D) configured to increase pullout strength comprising:
a screw head 104 and a shaft 105 having a distal tip (see tip portion opposite to head 104) extending along a central longitudinal axis 103, the shaft having a proximal portion 101 and a distal portion 102; and
an external thread (see thread 110 indicated by rectangular box in annotated Fig. 1D) helically wound around the shaft, each thread section having a crest (see tip of the thread section 110 in Fig. 1D), a root (see Fig. 1D), and leading (see upper portion of the thread 110 in Fig. 1D) and following flanks (see bottom portion of the thread 110 in Fig. 1D inside the rectangular box) connecting the crest to adjacent roots, wherein the leading flank faces toward the distal tip (see Fig. 1D) and is configured to enter into bone first and the following flank faces toward the screw head (see Fig. 1D) of the bone fastener, and wherein the following flank comprises a hook 112 configured to resist axial and lateral forces,
wherein the leading flank comprises a convex curved profile (see annotated Fig. 1D and Fig. 3 as a reference).
Regarding claim 16, Hyer discloses the fastener of claim 15, wherein the external thread includes non-linear leading and following flanks (see Fig. 1D and as a reference see Fig. 3).
Regarding claim 17, Hyer discloses the fastener of claim 15, wherein the hook includes a circular recess (see circular undercut in Fig. 1D and/or as a reference in Fig. 3).
Regarding claim 18, Hyer discloses the fastener of claim 15, wherein the hook defines a radial undercut (112, see annotated Fig. 1D) with a concave recessed surface (see Fig. 1D and as a reference see Fig. 3) extending between the crest and the root (see Fig. 1D).
Regarding claim 21, Hyer discloses the fastener of claim 1, wherein each thread section has at least five
Response to Arguments
Applicant’s arguments, filed 12/10/2025, with respect to claim(s) 1, 3-18 and 21 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIL K MAGAR whose telephone number is (571)272-8180. The examiner can normally be reached M-F 7:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christine Mills can be reached at (571) 272-8322. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIL K. MAGAR/Examiner, Art Unit 3675
/CHRISTINE M MILLS/Supervisory Patent Examiner, Art Unit 3675
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