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 .
This Office action is in response to the amendment filed 01/29/2026. Claims 1-4, 6 and 11 remain pending.
Election/Restrictions
Applicant elected Invention I, outrigger Species 1, and intramedullary nail species a in the reply filed on 09/04/2025.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because it is unclear if the identified “threads 125” of Fig. 3 are even threads. The drawings are too small to clearly identify what specific structure in Fig. 3 constitutes the threads 125 which are referenced in par. 0039 Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because in par. 0041 applicant references a draw bolt sleeve 120 (appears to appoint to the shaft 92 of driver) and internal threads 124 that mate with external threads 125 on the screwdriver. Fig. 3 includes references numerals 120, 124 and 125, however, they do not accurately identify the recited structure. Fig. 7 also includes a reference numeral 120 which is completely different structure from the identified 120 of Fig. 3. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because reference numeral 120 is used in Figs. 3A and 3 to identify different structure. Furthermore, the Drawings fail to show how internal drive inserts 100, 120 are held in position as disclosed in par. 0043. Magnified drawings to show the described structure is required. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-4, 6 and 11 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.
In claims 1 and 11, applicant recites that the central chamber has internal threads. It is noted that the chamber is identified at element 24 in Fig. 3 and does not appear to contain threads.
In claims 1 and 11, Applicant references an ovoid compression hole which is not identified in the drawings or specification as related to elected nail species a, shown in Fig. 14. Additionally, Applicant fails to identify the structure of the claimed ovoid compression hole that has a dimension that is greater than the mating diameter of an associated screw.
In claims 1 and 11, Applicant recites a drive insert (identified in the Specification as element 100 shown in Fig. 4) that can be rotated to drive an associated screw in each of the compression holes and the outrigger. Looking at Fig. 4, the drive insert 100 can’t move past the threads identified as element 106 due to a change in diameter of the lower threaded portion. Fig. 4 lacks any identification of an associated screw located in compression holes that are structured for contact with the drive insert 100.
Claim Objections
Claim 6 is objected to because of the following informalities: Claim 6 should be amended to structurally recite the relationship between the nail and outrigger. Currently, the wording that the “outrigger is external to but connected to the nail during surgery” appears to recite a method step. Additionally, “to” should be changed to --for-- in line 3.
Appropriate correction is required.
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)(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 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vicenzi et al. (U.S. 11,801,076 B2).
Concerning claim 1, Vicenzi et al. disclose an intramedullary nail system comprising an intramedullary nail (see Fig. 22A, element 1’) and at least three associated screws (received within openings 8a, 80d and 10), wherein the nail includes an elongated nail body member having a central chamber (see Fig. 16A below) extending along a long axis having internal threads (see Fig. 16B, element 12 and col. 7, lines 22-25) and at least three through holes (see Fig. 22A, elements 8a, 80d and 10), comprising a distal screw hole (8a), an intermediate screw hole (80d) and a proximal compression hole (10), each of which extend at an angle to the long axis, wherein two of the through holes are compression holes (80d and 10) which have a cross sectional configuration taken along the axis of the screws having a dimension that is greater than the mating diameter of an associated screw (e.g., see Fig. 16A, element 39) so as to form an ovoid compression hole, and a drive insert (see Fig. 16A, element 55; Fig. 14, element 55) that has external threads (see col. 10, lines 16-17), the drive insert positioned in the central chamber such that the drive insert can be rotated to drive an associated screw (39 – see col. 10, lines 49-56) in the proximal compression hole (see Figs. 16A-16B).
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Concerning claim 4, wherein at least one through hole is a distal hole (see Fig. 22A, element 8a) along the long axis and has a round cross-sectional configuration and has an associated screw to anchor the nail body member in the associated bone.
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.
Claim(s) 6 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vicenzi et al. (U.S. 11,801,076 B2) in view of Elghazaly et al. (U.S. 8,157,802 B2).
Vicenzi et al. disclose the invention substantially as described above. However, Vicenzi et al. do not explicitly an outrigger which is external to but connected to the nail during surgery to provide a drill guide to placement of the screws.
Elghazaly et al. disclose an intramedullary nail system (see Fig. 6) comprising an outrigger (500) which is external to but connected to the nail during surgery to provide a drill guide to placement of the screws in the same filed of endeavor.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vicenzi’s system to include an outrigger, as disclosed by Elghazaly et al., in order to precisely place the screws within the intramedullary nail openings. Besides greater accuracy, other benefits of an outrigger includes reduced radiation exposure as use of a fluoroscope is not necessary, decreased operative time, and simplified distal locking.
Concerning claim 11, Vicenzi et al. disclose an intramedullary nail system (see Fig. 22B) comprising an intramedullary nail (1’) and at least three associated screws (received within openings 8a, 80d and 10), wherein the nail includes an elongated nail body member having a central chamber (see Fig. 16A above) extending along a long axis having internal threads (12) and at least three through holes (see Fig. 22B, elements 8b, 80d and 10) extending at an angle to the long axis, wherein two of the through holes have a cross sectional configuration taken along the axis of the screws having a dimension that is greater than the mating diameter of an associated screw so as to form an ovoid compression hole (80d and 10), and the system includes one or more drive insert (see Fig. 14, element 55) which has external threads and which is engaged in the central chamber (see Fig. 16A, element 55) such that the drive insert can be rotated to drive an associated screw (39) in each of the compression holes.
However, Vicenzi et al. do not explicitly an outrigger which is external to but connected to the nail during surgery to provide a drill guide to placement of the screws.
Elghazaly et al. disclose an intramedullary nail system (see Fig. 6) comprising an outrigger (500) which is external to but connected to the nail during surgery to provide a drill guide to placement of the screws in the same field of endeavor.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vicenzi’s system to include an outrigger, as disclosed by Elghazaly et al., in order to precisely place the screws within the intramedullary nail openings. Besides greater accuracy, other benefits of an outrigger includes reduced radiation exposure as use of a fluoroscope is not necessary, decreased operative time, and simplified distal locking.
Response to Arguments
Applicant's arguments filed 01/29/2026 have been fully considered but they are not persuasive. In response to Applicant’s argument that “Vicenzi does not disclose the claimed relationship between the drive insert positioned in the central chamber and the associated screw in the proximal compression hole, in which rotation of the drive insert drives the associated screw in the proximal compression hole as claimed,” it is noted that col. 10, lines 49-64 disclose the claimed relationship. The drive insert (see Fig. 16A, element 55) is positioned in the central chamber (see Fig. 16A above) and acts to compress screw 39 thereby driving it in the proximal compression hole 10.
Regarding Applicant’s argument that Vicenzi’s cited openings do not each have the claimed ovoid geometry, sized and configured to permit the claimed compression travel of a respective associated screw,” it is noted that both elements 10 and 80d (see below) having an ovoid geometry, and are sized and configured to permit translation of a screw within.
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Regarding Applicant’s argument that “Vicenzi does not disclose a distal screw hole “along the long axis” as claimed,” Applicant’s attention is directed below which shows a distal screw hole along the long axis. It is further noted that it is unclear how opening 8a differs from distal screw hole 80 of Applicant’s invention (see Fig. 3 of the Application). If the shape of opening 8a is the issue, it is noted that opening 8b is also considered a distal screw hole.
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Regarding Applicant’s argument that “Elghazaly’s drill guide is designed to guide drilling for fixed locking holes and does not address guide placement in ovoid compression holes where the screw must later translate within the hole during compression actuation,” it is noted that claim 11 merely recites an outrigger that serves as a drill guide during surgery to implant the nail and screws. There is no requirement that the guide permit translation of a screw within any hole during compression actuation. Intramedullary nails rely on interlocking screws – placed through transverse holes in the nail – to control rotation and prevent axial collapse. The fundamental challenge is that these screw holes are inside the medullary canal, making freehand targeting imprecise and radio-graph dependent. The concept of attaching an outrigger to the proximal end of the nail and utilizing the rigid arm of the outrigger to guide drill bits in precise alignment with the locking holes is a well-known concept in the art that is successful because outriggers improve screw placement accuracy. After the screws have been accurately placed, the operating surgeon could remove the outrigger and then attach the driving tool to element 55 to cause translation of screw 39. The incorporation of an outrigger to place the screws accurately within the holes does not alter the operation of Vicenzi’s system. There is no requirement to add every structural feature disclosed by Elghazaly.
Conclusion
THIS ACTION IS MADE FINAL. 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 ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, 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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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773