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/Restrictions
Due to the amendments to claim 27, claim 27 now reads on the elected species of Figs. 17A-17B and has thereby been rejoined.
Drawings
The drawings were received on February 25, 2026. These drawings have been entered.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 16, 18, 21, 24, 27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al. (US 9,339,311 B1) in view of Gautheron et al. (FR 2 873 913 A1).
Claim 16. Tsai discloses a fracture fixation system, comprising:
a fixation element (sideplate 2 and sleeve 3) including a plate (sideplate 2) and a barrel (sleeve 3), the plate having an outer surface (see Fig. 5 inset) and an inner surface (see Fig. 5 inset) for placement against an exterior surface of a bone, and the barrel extending along a barrel axis and having a peripheral wall (see Fig. 5 inset) protruding from the inner surface of the plate, the fixation element defining a second passage (axial bore 5) through the plate and the barrel that extends along the barrel axis, wherein the second passage defines an internal shoulder (see Fig. 5 inset);
a lag screw (lag screw 1) extending from a proximal end (see Fig. 5 inset) to a distal end (see Fig. 5 inset) and configured to be inserted through the second passage defined by the plate and the barrel;
and a compression screw (compression screw 4), wherein a head (head 401) of the compression screw is configured to abut the internal shoulder (Figs. 3-6; col. 3, line 57 through col. 6, line 16).
Claim 24. Tsai discloses wherein the compression screw is configured to engage the proximal end of the lag screw (Figs. 3-6; col. 3, line 57 through col. 6, line 16).
Claim 27. Tsai discloses wherein the compression screw is configured to be threadably coupled to the proximal end of the lag screw (Figs. 3-6; col. 3, line 57 through col. 6, line 16).
Claim 29. Tsai discloses wherein the lag screw includes a distal threaded portion (see Fig. 5 inset) (Figs. 3-6; col. 3, line 57 through col. 6, line 16).
[AltContent: textbox (Internal Shoulder)][AltContent: textbox (Peripheral Wall)][AltContent: textbox (Inner Surface)][AltContent: textbox (Outer Surface)][AltContent: textbox (Proximal End)][AltContent: textbox (Distal Threaded Portion)][AltContent: textbox (Distal End)]
Tsai fails to disclose a first passage through the plate and the barrel that extends along the barrel axis (claim 16), a bolt extending from a proximal end to a distal end and configured to be inserted through the first passage defined by the plate and the barrel (claim 16), wherein a cross-section of the bolt taken perpendicular to a longitudinal axis of the bolt is non-circular (claim 18), and wherein the first passage is separated from the second passage by a center portion of the barrel (claim 21).
Gautheron teaches a fracture fixation system comprising: a fixation element (nail 3 and barrel 4) including a nail (nail 3) and a barrel (barrel 4), the fixation element defining first and second passages (channel 8 is the first passage; channel 7 is the second passage) through the plate and the barrel that each extend along a barrel axis; a bolt (cephalic rod 6) extending from a proximal end (end 6b) to a distal end (end 6a) and configured to be inserted through the first passage defined by the plate and the barrel; a lag screw (cephalic screw 5) configured to be inserted through the second passage; and a compression screw (unlabeled screw in Fig. 1); wherein a cross-section of the bolt taken perpendicular to a longitudinal axis of the bolt is non-circular (the cross-section taken along threads at end 6b would be non-circular due to the helical winding of the threads); wherein the first passage is separated from the second passage by a center portion (see Fig. 3, which shows that channel 7 is separated from channel 8) of the barrel; and wherein the configuration of the barrel and the inclusion of the bolt prevent rotation of the femoral head during the compression caused by the lag screw (see pg. 2, ll. 25-34; see also pg. 4 of the translation) (Figs. 1-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Tsai such to include a first passage through the plate and the barrel that extends along the barrel axis (claim 16), a bolt extending from a proximal end to a distal end and configured to be inserted through the first passage defined by the plate and the barrel (claim 16), wherein a cross-section of the bolt taken perpendicular to a longitudinal axis of the bolt is non-circular (claim 18), and wherein the first passage is separated from the second passage by a center portion of the barrel (claim 21), as suggested by Gautheron, as such a configuration of the barrel and the inclusion of the bolt would prevent rotation of the femoral head during the compression caused by the lag screw.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al. (US 9,339,311 B1) in view of Gautheron et al. (FR 2 873 913 A1) as applied to claim 18 above, and further in view of Watanabe et al. (US 2008/0281326 A1).
Tsai and Gautheron fail to teach wherein the cross-section of the bolt taken perpendicular to the longitudinal axis of the bolt is configured to resist rotation with respect to the fixation element (claim 23).
Watanabe teaches a bolt (stop 2060) received within a first passage (aperture 2006) of a fixation element (stabilizing structure 2002), wherein a cross-section of the bolt taken perpendicular to a longitudinal axis of the bolt is non-circular and configured to resist rotation with respect to the fixation element due to the presence of cooperating ratchet teeth on the bolt and in the first passage (see para. 0154) (Figs. 67-68; para. 0154).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Tsai by substituting the ratchet teeth of Watanabe for the threads of Gautheron as such is a simple substitution of one means for securing the bolt to the fixation element for another. In view of such a modification, the cross-section of the bolt taken perpendicular to the longitudinal axis of the bolt would be configured to resist rotation with respect to the fixation element (claim 23).
Claims 30 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al. (US 9,339,311 B1) in view of Gautheron et al. (FR 2 873 913 A1) as applied to claim 16 above, and further in view of Watanabe et al. (US 2008/0281326 A1) and Orlich (US 3,561,437 A).
Tsai and Gautheron fail to teach wherein a cross-section of the bolt taken perpendicular to a longitudinal axis of the bolt is triangular (claim 30) and wherein a cross-section of the bolt taken perpendicular to a longitudinal axis of the bolt is star-shaped (claim 32).
Watanabe teaches a bolt (stop 2060) received within a first passage (aperture 2006) of a fixation element (stabilizing structure 2002), wherein a cross-section of the bolt taken perpendicular to a longitudinal axis of the bolt is non-circular and configured to resist rotation with respect to the fixation element due to the presence of cooperating ratchet teeth on the bolt and in the first passage (see para. 0154) (Figs. 67-68; para. 0154).
Orlich teaches a bolt (nail 12), wherein a cross-section of the bolt taken perpendicular to a longitudinal axis of the bolt is triangular (due to flanges 18, 20, and 22 – see Fig. 2) or star-shaped (due to flanges 18, 20, and 22 forming a three-pointed star – see Fig. 2), wherein such a three-pointed shape prevents rotation relative to bone (see col. 4, ll. 43-45) (Figs. 1-2; col. 4, ll. 43-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Tsai by substituting the ratchet teeth of Watanabe for the threads of Gautheron as such is a simple substitution of one means for securing the bolt to the fixation element for another. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Tsai such that a cross-section of the bolt taken perpendicular to a longitudinal axis of the bolt is triangular (claim 30) and a cross-section of the bolt taken perpendicular to a longitudinal axis of the bolt is star-shaped (claim 32), as suggested by Orlich, as such shapes prevent rotation relative to bone.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al. (US 9,339,311 B1) in view of Gautheron et al. (FR 2 873 913 A1) as applied to claim 16 above, and further in view of Watanabe et al. (US 2008/0281326 A1) and Vestgaarden (US 2017/0049488 A1).
Tsai and Gautheron fail to teach wherein a cross-section of the bolt taken perpendicular to a longitudinal axis of the bolt is rectangular (claim 31).
Watanabe teaches a bolt (stop 2060) received within a first passage (aperture 2006) of a fixation element (stabilizing structure 2002), wherein a cross-section of the bolt taken perpendicular to a longitudinal axis of the bolt is non-circular and configured to resist rotation with respect to the fixation element due to the presence of cooperating ratchet teeth on the bolt and in the first passage (see para. 0154) (Figs. 67-68; para. 0154).
Vestgaarden teaches a bolt (body 10), wherein a cross-section of the bolt taken perpendicular to a longitudinal axis of the bolt is rectangular (see para. 0048), wherein such a shape prevents rotation of the bolt about its longitudinal center axis (see para. 0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Tsai by substituting the ratchet teeth of Watanabe for the threads of Gautheron as such is a simple substitution of one means for securing the bolt to the fixation element for another. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Tsai such a cross-section of the bolt taken perpendicular to a longitudinal axis of the bolt is rectangular (claim 31), as suggested by Vestgaarden, as such shapes prevent rotation of the bolt about its longitudinal center axis and thereby prevents rotation relative to bone.
Allowable Subject Matter
Claim 22 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to the claims 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
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 JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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