Prosecution Insights
Last updated: October 02, 2026
Application No. 19/237,215

Set Screw for Femoral Nail

Non-Final OA §102§103§112§DOUBLEPATENT
Filed
Jun 13, 2025
Priority
Mar 06, 2020 — provisional 62/985,981 +3 more
Examiner
CARTER, TARA ROSE E
Art Unit
3773
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Stryker Corporation
OA Round
1 (Non-Final)
81%
Grant Probability
Favorable
1-2
OA Rounds
1y 9m
Est. Remaining
90%
With Interview

Examiner Intelligence

Grants 81% — above average
81%
Career Allowance Rate
848 granted / 1051 resolved
+10.7% vs TC avg
Moderate +10% lift
Without
With
+9.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
26 currently pending
Career history
1073
Total Applications
across all art units

Statute-Specific Performance

§101
2.8%
-37.2% vs TC avg
§103
50.0%
+10.0% vs TC avg
§102
25.1%
-14.9% vs TC avg
§112
14.1%
-25.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1051 resolved cases

Office Action

§102 §103 §112 §DOUBLEPATENT
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 . Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. Claim(s) 1-5 is/are rejected on the ground of nonstatutory double patenting as being anticipated by claim(s) 3 of U.S. Patent No. 12349948. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include many more elements and are thus much more specific as shown below (note that underlined and/or bolded sections indicate comparable elements): Invention 19/237215 US Patent 12349948 1. An intramedullary intertrochanteric fracture fixation device, comprising: an intramedullary nail having a proximal portion and a distal portion, the proximal portion defining an opening having a first axis and an axial bore having a second axis, the axial bore extending through a proximal end of the intramedullary nail and into the opening; a neck screw extending through the opening along the first axis; and a set screw assembly within the proximal portion of the intramedullary nail and selectively moveable into the compartment for preventing rotational movement of the neck screw about the first axis, the set screw assembly including: a first member having a flexible portion, and a second member movably connected to the first member and including an extension in contact with the neck screw. 3. An intramedullary intertrochanteric fracture fixation device, comprising: an intramedullary nail having a proximal portion and a distal portion, the proximal portion defining an angulated opening having a first axis and an axial bore having a second axis, the axial bore extending through a proximal end of the intramedullary nail and into the angulated opening, the proximal portion further having a compartment defined by an upper stop, a lower stop and a sidewall, the sidewall of the compartment defining a slot; a neck screw extending through the angulated opening along the first axis, the neck screw having a length and an exterior surface defining a groove; and a set screw assembly pre-operatively assembled within the proximal portion of the intramedullary nail and selectively moveable into the compartment for preventing rotational movement of the neck screw about the first axis, the set screw assembly including: a fastening member having a head and a threaded shaft, a receiving member for receiving the threaded shaft, and a split ring disposed between the head of the fastening member and the receiving member, wherein the set screw assembly is cannulated and configured to receive a guidewire; wherein the set screw assembly comprises: a first member including a proximal portion and a distal portion, the proximal portion including a flange engageable with the upper stop to limit proximal movement of the set screw assembly, the distal portion including threading; and a second member including a ledge positionable within the slot of the compartment and engageable with the lower stop to limit distal movement of the set screw assembly, the second member further including threading adapted to couple to the threading of the first member, wherein threading the first member and the second member selectively adjusts a distance in which the second member extends through the angulated opening and into the groove of the neck screw; wherein the flange of the first member is expandable in a radial direction and transitionable between an unlocked condition and a locked condition. * the flange is comparable to the flexible portion recited in the invention **the ledge is comparable to the extension recited in the invention 2. The intramedullary intertrochanteric fracture fixation device of claim 1, wherein the set screw assembly is cannulated and configured to receive a guidewire. Claim 3, see bolded section above 3. The intramedullary intertrochanteric fracture fixation device of claim 1, wherein the neck screw includes a groove, the extension disposed within the groove. Claim 3, see bolded section above 4. The intramedullary intertrochanteric fracture fixation device of claim 1, wherein the set screw assembly is pre-operatively assembled with the nail. Claim 3, see bolded section above 5. The intramedullary intertrochanteric fracture fixation device of claim 1, wherein the first and second members are threadably connected. Claim 3, see bolded section above 6. The intramedullary intertrochanteric fracture fixation device of claim 5, wherein rotation of the first member with respect to the second member in a first direction reduces a force applied by the extension on the neck screw and rotation of the first member with respect to the second member in a second direction increases a force applied by the extension on the neck screw. 7. The intramedullary intertrochanteric fracture fixation device of claim 1, wherein the flexible portion includes a plurality of flanges and an internal cavity. 8. The intramedullary intertrochanteric fracture fixation device of claim 7, wherein each flange is separated from another by a gap. 9. The intramedullary intertrochanteric fracture fixation device of claim 7, wherein during assembly, the flanges flex radially inward until disposed within a compartment of the proximal portion. 10. The intramedullary intertrochanteric fracture fixation device of claim 9, wherein upon full assembly, the flanges engage an upper ledge of the compartment. 11. A set screw assembly, comprising: a first member having a plurality of flexible flanges and a first threaded portion; and a second member having an extension and a second threaded portion, wherein the first and second threaded portions are threaded to each other and rotation of the first member with respect to the second member in a first direction causes a length of the screw assembly to increase and rotation of the first member with respect to the second member in a second direction causes the length to decrease. 12. The set screw assembly of claim 11, wherein the first and second members are cannulated. 13. The set screw assembly of claim 11, wherein the second member includes an extension at a distal end thereof. 14. The set screw assembly of claim 11, wherein each flange is separated from another by a gap and surrounds an interior cavity. 15. The set screw assembly of claim 14, wherein each flange includes angled surfaces. 16. The set screw assembly of claim 11, wherein the first member includes an intermediate portion and the second member includes a lateral flange designed to contact the intermediate portion upon rotation of the first member with respect to the second member. 17. A nail assembly comprising: the set screw assembly of claim 11; and an intramedullary nail. 18. The nail assembly of claim 17, wherein the set screw assembly is disposed in a proximal portion the intramedullary nail. 19. The nail assembly of claim 18, further comprising a neck screw extending through the intramedullary nail, wherein the set screw assembly engages the neck screw. 20. The nail assembly of claim 19, wherein the second member includes an extension at a distal end thereof disposed in a groove of the neck screw. Claim(s) 1-4, 7, 8 is/are rejected on the ground of nonstatutory double patenting as being anticipated by claim(s) 7 and 10-13 of U.S. Patent No. 11857228. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include many more elements and are thus much more specific as shown below (note that underlined and/or bolded sections indicate comparable elements): Invention 19/237215 US Patent 11857228 1. An intramedullary intertrochanteric fracture fixation device, comprising: an intramedullary nail having a proximal portion and a distal portion, the proximal portion defining an opening having a first axis and an axial bore having a second axis, the axial bore extending through a proximal end of the intramedullary nail and into the opening; a neck screw extending through the opening along the first axis; and a set screw assembly within the proximal portion of the intramedullary nail and selectively moveable into the compartment for preventing rotational movement of the neck screw about the first axis, the set screw assembly including: a first member having a flexible portion, and a second member movably connected to the first member and including an extension in contact with the neck screw. 7. A set screw assembly having a longitudinal axis and configured to be received within a compartment of an intramedullary nail, the intramedullary nail having an angulated opening for receiving a neck screw, the set screw assembly comprising: a first member including a proximal portion and a distal portion extending along a longitudinal axis, the proximal portion including at least one flange being moveable in a radial direction relative to the longitudinal axis between an unlocked condition and a locked condition, the distal portion including a threading; and a second member including a sidewall extending between a proximal end and a distal end, the sidewall defining an interior surface having a threading for threadably mating with the distal portion of the first member, the second member further including a lateral flange sized and configured to engage an interior surface of the compartment of the intramedullary nail for rotationally stabilizing the second member within the compartment; wherein the distal end of the second member includes an extension configured to extend through the angulated opening and engage the neck screw. Claims 10-13: 10. An intramedullary intertrochanteric fracture fixation device, comprising: an intramedullary nail having a longitudinal axis, a proximal portion and a distal portion, the proximal portion defining an angulated opening and an axial bore extending through a proximal end of the intramedullary nail along the longitudinal axis and into the angulated opening, the proximal portion further having a compartment defined by an upper stop, a lower stop and a sidewall, the sidewall of the compartment defining a slot; a neck screw extending through the angulated opening and having an exterior surface with a groove; and a set screw disposed within the compartment of the intramedullary nail, the set screw comprising: a first member including a proximal portion and a distal portion, the proximal portion including a plurality of flanges being moveable in a radial direction relative to the longitudinal axis between an unlocked condition and a locked condition, the plurality of flanges being annularly spaced from one another to define a first cavity; a second member including a sidewall extending between a proximal end and a distal end, the sidewall defining a second cavity for receiving the distal portion of the first member, the second member further including an extension extending through the angulated opening and into a groove of the neck screw, and a lateral flange disposed within the slot of the compartment; and a third member rotatably disposed within the first cavity such that rotation of the third member in a first direction transitions the plurality of flanges from the unlocked condition to the locked condition. 2. The intramedullary intertrochanteric fracture fixation device of claim 1, wherein the set screw assembly is cannulated and configured to receive a guidewire. 11. The set screw assembly of claim 10, wherein the first member, the second member and the third member are cannulated such that when the first member, the second member and the third member are coupled together the set screw assembly is configured to receive a guidewire. 3. The intramedullary intertrochanteric fracture fixation device of claim 1, wherein the neck screw includes a groove, the extension disposed within the groove. Claims 10-13, see bolded section above 4. The intramedullary intertrochanteric fracture fixation device of claim 1, wherein the set screw assembly is pre-operatively assembled with the nail. Claims 10-13, see bolded section above 5. The intramedullary intertrochanteric fracture fixation device of claim 1, wherein the first and second members are threadably connected. 6. The intramedullary intertrochanteric fracture fixation device of claim 5, wherein rotation of the first member with respect to the second member in a first direction reduces a force applied by the extension on the neck screw and rotation of the first member with respect to the second member in a second direction increases a force applied by the extension on the neck screw. 7. The intramedullary intertrochanteric fracture fixation device of claim 1, wherein the flexible portion includes a plurality of flanges and an internal cavity. Claims 10-13, see bolded section above 8. The intramedullary intertrochanteric fracture fixation device of claim 7, wherein each flange is separated from another by a gap. Claims 10-13, see bolded sections above 9. The intramedullary intertrochanteric fracture fixation device of claim 7, wherein during assembly, the flanges flex radially inward until disposed within a compartment of the proximal portion. 10. The intramedullary intertrochanteric fracture fixation device of claim 9, wherein upon full assembly, the flanges engage an upper ledge of the compartment. 11. A set screw assembly, comprising: a first member having a plurality of flexible flanges and a first threaded portion; and a second member having an extension and a second threaded portion, wherein the first and second threaded portions are threaded to each other and rotation of the first member with respect to the second member in a first direction causes a length of the screw assembly to increase and rotation of the first member with respect to the second member in a second direction causes the length to decrease. 12. The set screw assembly of claim 11, wherein the first and second members are cannulated. 13. The set screw assembly of claim 11, wherein the second member includes an extension at a distal end thereof. 14. The set screw assembly of claim 11, wherein each flange is separated from another by a gap and surrounds an interior cavity. 15. The set screw assembly of claim 14, wherein each flange includes angled surfaces. 16. The set screw assembly of claim 11, wherein the first member includes an intermediate portion and the second member includes a lateral flange designed to contact the intermediate portion upon rotation of the first member with respect to the second member. 17. A nail assembly comprising: the set screw assembly of claim 11; and an intramedullary nail. 18. The nail assembly of claim 17, wherein the set screw assembly is disposed in a proximal portion the intramedullary nail. 19. The nail assembly of claim 18, further comprising a neck screw extending through the intramedullary nail, wherein the set screw assembly engages the neck screw. 20. The nail assembly of claim 19, wherein the second member includes an extension at a distal end thereof disposed in a groove of the neck screw. Thus, the invention of US Patent 12349948, claim 3, and US Patent 11857228, claims 7 and 10-13, respectively, are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims. 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. Claims 1-20 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 1 recites the limitation "the compartment" in line 7. There is insufficient antecedent basis for this limitation in the claim. Claim 11 recites the limitation "the screw assembly" in line 5. There is insufficient antecedent basis for this limitation in the claim. Claim Rejections - 35 USC § 102 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) 1-3 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Mikhail (US 20110196370). With respect to claim 1, Mikhail discloses an intramedullary intertrochanteric fracture fixation device (abstract), comprising: an intramedullary nail (304) having a proximal portion and a distal portion, the proximal portion defining an opening (e.g., 308) having a first axis (oblique to the longitudinal axis) and an axial bore (310) having a second axis (e.g., longitudinal axis, see para. 66), the axial bore extending through a proximal end of the intramedullary nail and into the opening (see para. 66 and para. 50, note that para. 50 discusses these elements being located either on a proximal or distal end of the intramedullary nail); a neck screw (302) extending through the opening along the first axis; and a set screw assembly (306) within the proximal portion of the intramedullary nail and selectively moveable (via spring 340) into a compartment (e.g., within the intramedullary nail) for preventing rotational movement of the neck screw about the first axis (see fig. 19-26), the set screw assembly including: a first member (318+340) having a flexible portion (340, see para. 68), and a second member (320) movably connected to the first member (see para. 70) and including an extension (e.g., 326 and/or 328) in contact with the neck screw (see para. 70). PNG media_image1.png 539 869 media_image1.png Greyscale PNG media_image2.png 431 679 media_image2.png Greyscale As for claim 2, Mikhail further discloses the intramedullary intertrochanteric fracture fixation device of claim 1, wherein the set screw assembly is cannulated and configured to receive a guidewire (see para. 60). As for claim 3, Mikhail further discloses the intramedullary intertrochanteric fracture fixation device of claim 1, wherein the neck screw includes a groove (318), the extension disposed within the groove (see para. 66). Claim(s) 1 and 7-10 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Elghazaly (US 20120197255). With respect to claim 1, Elghazaly discloses an intramedullary intertrochanteric fracture fixation device (e.g., see fig. 1), comprising: an intramedullary nail (102) having a proximal portion and a distal portion, the proximal portion defining an opening (e.g., 120) having a first axis (oblique to the longitudinal axis) and an axial bore (113) having a second axis (e.g., longitudinal axis, see para. 98), the axial bore extending through a proximal end of the intramedullary nail and into the opening (see fig. 1 and para. 98-99); a neck screw (104) extending through the opening along the first axis; and a set screw assembly (200) within the proximal portion of the intramedullary nail and selectively moveable into a compartment (e.g., within 111 of the intramedullary nail) for preventing rotational movement of the neck screw about the first axis (see para. 97, 102), the set screw assembly including: a first member (180) having a flexible portion (186, see para. 106), and a second member (160) movably connected to the first member (e.g., before 186 is snap fitted to 167) and including an extension (e.g., shaft 163) in contact with the neck screw (see fig. 4). As for claim 7, Elghazaly further discloses the intramedullary intertrochanteric fracture fixation device of claim 1, wherein the flexible portion includes a plurality of flanges (188) and an internal cavity (e.g., 182, see para. 106). As for claim 8, Elghazaly further discloses the intramedullary intertrochanteric fracture fixation device of claim 7, wherein each flange is separated from another by a gap (190, see para. 106). As for claim 9, Elghazaly further discloses the intramedullary intertrochanteric fracture fixation device of claim 7, wherein during assembly, the flanges flex radially inward until disposed within a compartment of the proximal portion (see para. 106). 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) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mikhail (US 20110196370), as applied to claim 1 above, in view of Zehtab (US 20160199109). As for claim 4, Mikhail does not appear to teach wherein the set screw assembly is pre-operatively assembled with the nail. Zehtab, also drawn to intramedullary intertrochanteric fracture fixation devices (e.g., 100, see para. 33), teaches wherein the set screw assembly is pre-operatively assembled with the nail (see para. 34, fig. 2, 2a, 2b) in order to provide a known assembly configuration that allows for easier installation of the device (see para. 34). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mikhail wherein the set screw assembly is pre-operatively assembled with the nail, in view of Zehtab, in order to provide a known assembly configuration that allows for easier installation of the device. As for claim 5, Mikhail does not teach wherein the first and second members are threadably connected. Zehtab, also drawn to intramedullary intertrochanteric fracture fixation devices (e.g., 100, see para. 33), teaches wherein the first and second members are threadably connected (e.g., via 253, 271, see fig. 2j, 2k and para. 36-37) in order to provide a known mechanical connecter that provides the same function of a tight engagement between two elements that is adjustable as needed (see para. 36-37). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the connection (e.g., 384, 372) between the first and second members wherein the first and second members are threadably connected, as a matter of engineering design choice, in view of Zehtab, in order to provide a known mechanical connecter that provides the same function of a tight engagement between two elements that is adjustable as needed. As for claim 6, Mikhail, as modified by Zehtab, further teaches the intramedullary intertrochanteric fracture fixation device of claim 5, wherein rotation of the first member with respect to the second member in a first direction reduces a force applied by the extension on the neck screw and rotation of the first member with respect to the second member in a second direction increases a force applied by the extension on the neck screw (see para. 72-73). Claim(s) 11, 13-15 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cole (US 20070100343) in view of Yamazaki (US 20090326534). With respect to claim 11, Cole teaches a set screw assembly (104+106), comprising: a first member (104) having a plurality of flexible flanges (separated by slots 113, see fig. 5a-5c below and para. 68); and a second member (106) having an extension (e.g., head or unthreaded portion of shaft 112) and a second threaded portion (112/114), and relative rotation between the second member and the first member in a first direction causes a length of the set screw assembly to increase and relative rotation between the second member and the first member in a second direction causes the length to decrease (see para. 70 and note that when 106 bears against 116, 104 is compressed and when 106 is rotated the opposite direction, the compression is released and the length of 104 is restored). PNG media_image3.png 620 997 media_image3.png Greyscale Cole (embodiment of fig. 5a-5c) further teaches use of alignment tabs 110 that cooperate with alignment slots 109 of an intramedullary nail (102) to aid in alignment of the first member with the intramedullary nail (see para. 66, 67, 70). Cole does not teach a first threaded portion; wherein the first and second threaded portions are threaded to each other such that relative rotation between the first and second members causes the increase or decrease in the length of the set screw assembly. Yamazaki, also drawn to set screw assemblies used with intramedullary nails (see abstract and fig. 2) teaches first and second members (70 and 75, respectively) threaded to each other (note that first and second members are threaded to each other because threads 71 and 76 contact each other and rotation of 76 drives rotation of 71) in order to provide two functions: a) alignment between the first member and the intramedullary nail (via 71 and 38, see para. 44) and b) driving/positioning the first member relative to the intramedullary nail (via rotation of second member 75 within the intramedullary nail to drive the first member 70, see para. 44). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Cole to include a first threaded portion; wherein the first and second threaded portions are threaded to each other such that relative rotation between the first and second members causes the increase or decrease in the length of the set screw assembly, as a matter of engineering design choice, in order to provide an alternate equivalent mechanical structure that will result in providing the same two functions: a) alignment between the first member and the intramedullary nail and b) driving/positioning the first member relative to the intramedullary nail. As for claim 13, Cole, as modified Yamazaki, further teaches the set screw assembly of claim 11, wherein the second member includes an extension (e.g., note that the unthreaded portion of the shaft 112) at a distal end thereof (see fig. 5a-5c above). As for claim 14, Cole, as modified Yamazaki, further teaches the set screw assembly of claim 11, wherein each flange is separated from another by a gap (113) and surrounds an interior cavity (see para. 68 and note that 104 is tubular). As for claim 15, Cole, as modified Yamazaki, further teaches the set screw assembly of claim 14, wherein each flange includes angled surfaces (note that each contains ninety-degree angles). As for claim 17, Cole, as modified Yamazaki, further teaches a nail assembly comprising: the set screw assembly of claim 11; and an intramedullary nail (102). As for claim 18, Cole, as modified Yamazaki, further teaches the nail assembly of claim 17, wherein the set screw assembly is disposed in a proximal portion the intramedullary nail (see fig. 5a-5c above). As for claim 19, Cole, as modified Yamazaki, further teaches the nail assembly of claim 18, further comprising a neck screw (fixation pin) extending through the intramedullary nail, wherein the set screw assembly engages the neck screw (see para. 70). Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cole (US 20070100343) and Yamazaki (US 20090326534), as applied to claim 11 above, in view of Haidukewych (US 20100249781). As for claim 12, Cole, as modified Yamazaki, further teaches wherein the first member is cannulated (see para. 16, 68), but appears to be silent regarding the second member being cannulated. Haidukewych, also drawn to set screw assemblies, teaches a set screw assembly (150) wherein both the first and second members (152 and 160, respectively) are cannulated (see fig. 5 and para. 34-35) in order to allow unobstructed passage of a guidewire, therethrough, as is well known in the art for aiding in implantation of an intramedullary nail (see para. 34-35). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Cole, as modified Yamazaki, wherein the second member is cannulated, in view of Haidukewych, in order to allow unobstructed passage of a guidewire, therethrough, as is well known in the art for aiding in implantation of an intramedullary nail. Reasons for Allowance The following is a statement of reasons for the indication of allowable subject matter: The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in claim 10. In particular, none of the cited references teach or suggest wherein upon full assembly, the flanges engage an upper ledge of the compartment as required by claim 10. The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in claim 16. In particular, none of the cited references teach or suggest wherein the first member includes an intermediate portion and the second member includes a lateral flange designed to contact the intermediate portion upon rotation of the first member with respect to the second member, as required by claim 16. The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in claim 20. In particular, none of the cited references teach or suggest wherein the second member includes an extension at a distal end thereof disposed in a groove of the neck screw, as required by claim 20. Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.” Allowable Subject Matter Claims 10, 16 and 20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /TARA ROSE E CARTER/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
Read full office action

Prosecution Timeline

Jun 13, 2025
Application Filed
Aug 24, 2026
Non-Final Rejection mailed — §102, §103, §112
Sep 17, 2026
Interview Requested

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12746041
POST-OPERATIVELY ADJUSTABLE ANGLED ROD
1y 10m to grant Granted Sep 29, 2026
Patent 12721682
SYSTEMS, METHODS, AND DEVICES FOR DEVELOPING PATIENT-SPECIFIC SPINAL TREATMENTS, OPERATIONS, AND PROCEDURES
2y 2m to grant Granted Sep 01, 2026
Patent 12721732
EXPANDABLE INTERVERTEBRAL IMPLANT
1y 10m to grant Granted Sep 01, 2026
Patent 12714573
EXPANDABLE IMPLANT ASSEMBLY WITH MODULAR ENDPLATES
2y 4m to grant Granted Aug 25, 2026
Patent 12714466
EXTERNAL FIXATION STRUT
2y 0m to grant Granted Aug 25, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

Strategy Recommendation AI-generated — please review before filing

Get a prosecution strategy drawn from examiner precedents, rejection analysis, and claim mapping.
Typically takes 5-10 seconds — AI-generated, attorney review required before filing

Prosecution Projections

1-2
Expected OA Rounds
81%
Grant Probability
90%
With Interview (+9.7%)
3y 0m (~1y 9m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1051 resolved cases by this examiner. Grant probability derived from career allowance rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month