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 .
Information Disclosure Statement
In the IDS dated 11/18/2025 the IDS states US Patent 10,065,961 in the English translation of JP 2016-5004961. The documents do not match as the US Patent is to a material application and not a nail system.
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) 1 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hedgeland et al. (US Pub 2019/0038326) in view of Gotfried (US Patent 5,429,641).
With respect to claim 1, Hedgeland discloses a targeting system (see figures 1A below) for inserting a lag screw (fig 1A, 119) into an intramedullary nail (fig 1A, 109), the system comprising: an intramedullary nail (fig 1A, 109) having a proximal end (fig 1A, 111) with a proximal through opening (fig 1A, 123) and a distal end (fig 1A, 110) ; a nail insertion handle (fig 1A, 103) including a coupling portion (See fig 1A below and figure 2A) to removably couple to the proximal end of the intramedullary nail, a handle portion (fig 1A, 105), and an aiming guide (fig 1A, end of 107) having an opening that aligns with the proximal through opening in the intramedullary nail; wherein the handle portion includes an anteversion alignment system (fig 1A, 105 and paragraph 14, the J-shaped handle allows for proper alignment) configured to optimally insert a lag screw into the proximal through opening in the intramedullary nail, an anti-rotation system (fig 1A, 113, 115, 127 and 129) configured to stabilize the bone when the lag screw is inserted, and a lag screw aiming assembly (fig 1A, 117) configured to reliably insert down to the bone, thereby defining a trajectory to the proximal through opening in the intramedullary nail and the anti-rotation system includes a plurality of anti-rotation holes (fig 1A, 127, 129) and anti-rotation guidewires (fig 1A, 113, 115) positionable into bone. With respect to claim 6, Hedgeland discloses the claimed invention with anti-rotation holes (paragraph 60 discloses that the number and orientation of the holes can include up to 4) include an upper pair of holes (paragraph 60 discloses the holes can be more proximal) converging distally at a first angle (Paragraph 112, discloses anti-rotation holes can be convergent) and a lower pair of hole (paragraph 60, discloses the holes can be arranged distally) converging (paragraph 112) distally at a second angle, wherein the second angle is greater than the first angle (fig 17G and H shows holes converging at different angles).
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Hedgeland does not disclose anti-rotation sleeves positionable through the holes, and anti-rotation guide wires positionable through the sleeves and into bone, the anti-rotation sleeves each having a proximal end and a distal end, the distal end extending beyond the handle and the proximal end configured to positioned adjacent to the bone.
Gotfried discloses an anti-rotation sleeve (fig 8. 20, 22) positionable through the hole (hole in 21 for the sleeve), and anti-rotation guide wire (see fig 8 below) positionable through the sleeve and into bone, the anti-rotation sleeve each having a proximal end (fig 8, 20) and a distal end (fig 8, 22), the distal end extending beyond the handle (see fig 8 below) and the proximal end (see fig 8 below) configured to positioned adjacent to the bone to firmly hold the position of the tool (col. 5, ll. 5-10).
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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 device of Hedgeland to include anti-rotation sleeves positionable through the holes, and anti-rotation guide wires positionable through the sleeves and into bone, the anti-rotation sleeves each having a proximal end and a distal end, the distal end extending beyond the handle and the proximal end configured to positioned adjacent to the bone in view of Gotfried in order to firmly hold the position of the tool.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hedgeland in view of Gotfried as applied to claim 1 above, and further in view of Felder et al (US Pub 2014/0214045).
With respect to claims 2 and 3, Hedgeland in view of Gotfried discloses the claimed invention except for wherein the handle portion defines an anteversion guide wire hole along a center plane of the nail insertion handle and a pair of radiopaque goal posts positioned on opposite sides of the guide wire hole wherein the radiopaque goal posts includes two parallel rows of pins retained in the handle portion, and when the goal posts are centered in parallel and a guide wire positioned through the anteversion guide wire hole is centered with a neck and head of the bone, an optimal anteversion position is found for lag screw insertion.
Felder discloses (see fig 17 below) wherein a handle portion (Fig 17, 108) defines an anteversion guide wire hole (fig 17, 128) along a center plane of the nail insertion handle and a pair of radiopaque goal posts (fig 17, 136) positioned on opposite sides of the guide wire hole wherein the radiopaque goal posts includes two parallel rows of pins (fig 17, 136) retained in the handle portion, and when the goal posts are centered in parallel and a guide wire (Fig 17, 170) positioned through the anteversion guide wire hole is centered with a neck and head of the bone, an optimal anteversion position is found for lag screw insertion(fig 18 to fig 20 shows the aligning to allow for fixing the alignment under x-ray to verify the correct orientation (paragraphs 38-39).
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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 device of Hedgeland in view of Gotfried to include wherein the handle portion defines an anteversion guide wire hole along a center plane of the nail insertion handle and a pair of radiopaque goal posts positioned on opposite sides of the guide wire hole wherein the radiopaque goal posts includes two parallel rows of pins retained in the handle portion, and when the goal posts are centered in parallel and a guide wire positioned through the anteversion guide wire hole is centered with a neck and head of the bone, an optimal anteversion position is found for lag screw insertion in view of Felder in order to allow for fixing the alignment under x-ray to verify the correct orientation.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hedgeland in view of Gotfried as applied to claim 1 above, and further in view of in view of Greig (US Patent 4,969,889).
With respect to claim 5, Hedgeland in view of Gotfried discloses the claimed invention except for wherein the anti-rotation holes each include a retention pin configured to secure the anti-rotation sleeve in the anti-rotation hole.
Greig discloses wherein the anti-rotation holes (fig 1, 38) each include a retention pin (fig 1, 56) configured to secure the anti-rotation sleeve in the anti-rotation hole to aid in positioning the wire (col. 1, ll. 24-35).
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 device of Hedgeland in view of Gotfried to include wherein the anti-rotation holes each include a retention pin configured to secure the anti-rotation sleeve in the anti-rotation hole in view of Greig in order to aid in positioning the wire
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hedgeland et al. in view of Gotfried as applied to claim 1 above, and further in view of Zastrozna (US Pub 2020/0352659).
With respect to claim 7, Hedgeland in view of Gotfried discloses wherein the lag screw aiming assembly (fig 1, 117) includes a driver sleeve (fig 1, 117) positionable through the opening in the aiming guide (fig 2, 131), a wire sleeve (Fig 17, 612) positionable through the driver sleeve (fig 1), and a trocar (paragraph 106) positionable through the wire sleeve but does not disclose wherein a distal tip of the wire sleeve includes cutting flutes.
Zastrozna discloses wherein a distal tip of a sleeve (Fig 1, 70) includes cutting flutes (paragraph 47) to enhance the user’s ability to advance to sleeve (paragraph 47).
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 device of Hedgeland in view of Gotfried to include wherein a distal tip of the wire sleeve includes cutting flutes in view of Zastrozna in order to enhance the user’s ability to advance to sleeve.
Claim(s) 8, 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Powell (US Pub 2015/0150568) in view of Perrett et al. (US Patent 4,341,206) and in view of Zander (US Pub 2004/0260307).
With respect to claim 8, Powell discloses a targeting system (see figures 1, 3a and 11c below) comprising: an intramedullary nail (fig 11c, 70) having a proximal end (top) and a distal end (bottom); a nail insertion handle (fig 11c, 90) including a coupling portion (see fig 11c below) to removably couple to the proximal end of the intramedullary nail, a handle portion (fig 11c, 90), and an aiming guide (fig 11c, below) having an opening (fig 11c, 92) that aligns with an opening in the intramedullary nail; a driver sleeve (fig 1, 30) positionable through the opening in the aiming guide; a wire sleeve (fig 1, 20) positionable through the driver sleeve, and a guide wire (fig 134, 600) positionable through the wire sleeve. With respect to claim 11, Powell discloses wherein the wire sleeve includes an enlarged head (fig 3a, 218) portion defining a spring cut (fig 3a, 2050, 2060) that enable the wire sleeve to snap into the driver sleeve. With respect to claim 12, Powell discloses further comprising a trocar (fig 1, 10) positionable through the wire sleeve, the trocar including a shaft with a sharp distal tip (See fig 1 below) configured to facilitate insertion through soft tissue.
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With respect to claim 8, Powell discloses the claimed invention except for the wire sleeve having a plurality of graduated markings, wherein when the wire sleeve is flush with the guide wire, a reading of the driver sleeve next to the graduated markings indicates an optimal lag screw length and does not disclose wherein the trocar has a bent shaft to facilitate retention within the wire sleeve.
Perrett et al. discloses a wire sleeve (fig 2, 11) having a plurality of graduated markings (fig 2, 11a), wherein when the wire sleeve is flush with the guide wire (fig 2, 7), a reading of the driver sleeve (fig 3, 17) next to the graduated markings indicates an optimal lag screw length (col. 3, ll. 15-25) to permit the surgeon with great accuracy to determine the proper depth and configuration for the screw (col. 2, ll. 25-26).
Zander discloses a trocar (fig 1, 30) has a bent shaft (fig 1, 54) to facilitate retention within a sleeve (fig 1, 10) to fix the relative positions of the sleeve and trocar (paragraph 20).
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 device of Powell to include the wire sleeve having a plurality of graduated markings, wherein when the wire sleeve is flush with the guide wire, a reading of the driver sleeve next to the graduated markings indicates an optimal lag screw length in view of Perrett in order to permit the surgeon with great accuracy to determine the proper depth and configuration for the screw and 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 device of Powell in view of Perrett to include the trocar has a bent shaft to facilitate retention within the wire sleeve in view of Zander in order to fix the relative positions of the sleeve and trocar.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Powell in view of Perrett et al. and in view of Zander as applied to claim 8 above, and further in view of Hedgeland et al. (US Pub 2019/0038326).
With respect to claim 9, Powell in view of Perrett and in view of Zander discloses the driver sleeve includes a tubular body (See fig 1 above) but does not disclose the body with a plurality of teeth configured to engage a ratchet within the aiming arm.
Hedgeland discloses a driver sleeve body (fig 2C, 117) with a plurality of teeth (Fig 2c, 133) configured to engage a ratchet (fig 2C, 135) within the aiming arm (fig 2c, 107) to prevent the accidental release of the sleeve (paragraph 63).
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 device of Powell in view of Perrett and in view of Zander to include the body with a plurality of teeth configured to engage a ratchet within the aiming arm in view of Hedgeland in order to prevent the accidental release of the sleeve.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Powell in view of Perrett et al. and in view of Zander as applied to claim 8 above, and further in view of Zastrozna (US Pub 2020/0352659).
With respect to claim 10, Powell in view of Perrett and in view of Zander discloses the claimed invention except for wherein a distal tip of the wire sleeve includes cutting flutes.
Zastrozna discloses wherein a distal tip of a sleeve (Fig 1, 70) includes cutting flutes (paragraph 47) to enhance the user’s ability to advance to sleeve (paragraph 47).
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 device of Powell in view of Perrett and in view of Zander to include wherein a distal tip of the wire sleeve includes cutting flutes in view of Zastrozna in order to enhance the user’s ability to advance to sleeve.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Powell in view of Perrett et al. and in view of Zander as applied to claim 8 above, and further in view of Euteneuer (US pub 2016/0135806).
With respect to claim 13, Powell in view of Perrett and in view of Zander discloses the claimed invention except for wherein the trocar includes a head portion with a male mating member receivable in a corresponding female mating member in the wire sleeve such that the trocar and wire sleeve turn together to help drive through soft tissue.
Euteneuer discloses wherein a trocar includes a head portion (fig 9B, 302) with a male mating member (paragraph 80 , keyed) receivable in a corresponding female mating member (paragraph 80, keyed and fig 10A, 316, grooves) in a sleeve (fig 9B, 304) such that the trocar and sleeve turn together to help drive through soft tissue to maintain the relative rotational position (paragraph 82).
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 device of Powell in view of Perrett and in view of Zander to include wherein the trocar includes a head portion with a male mating member receivable in a corresponding female mating member in the wire sleeve such that the trocar and wire sleeve turn together to help drive through soft tissue in view of Euteneuer in order to maintain the relative rotational position.
Response to Arguments
Applicant’s arguments, see remarks, filed 2/9/2026, with respect to the USC 112 rejection of claims 9-14 have been fully considered and are persuasive. The USC 112 rejection of claims 9-14 has been withdrawn.
Applicant’s arguments, with respect to the U.S.C. 101 rejection of claim 3 have been fully considered and are persuasive. The U.S.C. 101 rejection of claim 3 has been withdrawn.
Applicant’s arguments with respect to claim(s) 1-3 and 5-7 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.
Applicant's arguments filed 2/9/2026 have been fully considered but they are not persuasive. With respect to amended claim 8, the applicant argues the shaft of Zander is not bent to facilitate the retention. The examiner respectfully disagrees. The claim does not specify what portion of the trocar is a shaft and that the shaft must be inserted into the sleeve to retain the trocar. The bent handle shaft of the Zander Trocar meets the claimed limitation. If the claim clarified the shaft is inserted into the sleeve and bent within the sleeve it would overcome the rejection.
The applicant does not individually argue the other 103 rejections.
The rejections is deemed proper.
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.
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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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