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 .
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) 1-8 and 14-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gurtowski (US Pub 2007/0270864).
With respect to claim 1, Gurtowski discloses a system for inserting a locking screw into a nail hole of an intramedullary nail inserted in a medullary canal of a bone (see figures 12, 13 and 15 below), the system comprising: a trocar (fig 12, 102) having a tubular structure that is open at both sides, configured to attach to a bone (fig 12) wherein the trocar is configured to sequentially receive and guide multiple different components including a drill centralizer, a guide, and a sleeve (figs 12, 13 and 15 below trocar 102 is shown used with each of the drill centralizer, guide and sleeve while remaining in the same position); a drill centralizer (fig 15, 108) having an elongated shape and comprising a sharp centralizer tip (fug 13, shown punctured into the bone) configured to puncture the bone, wherein the drill centralizer is configured to be inserted into the trocar and puncture the bone and create a starter hole in the bone (fig 13); a sleeve (fig 12, 104) having a tubular structure that is open at both sides, configured to be inserted into the trocar, and guide a camera (fig 12, 100) to a center of a hole drilled in the bone (paragraph 66); a guide (fig 13, 106) having a tubular structure that is open at both sides, configured to be inserted into the trocar, accommodate a drill bit (fig 15, 110) and guide the drill bit to the starter hole punctured on the surface of the bone, and accommodate the drill bit during the drilling in the bone; and a drill bit (fig 15, 110) of a drilling device, wherein the drill bit comprising a drill bit tip (See fig 15 below) configured to be in contact with the bone surface at an early stage of drilling, to be accommodated in the start hole punctured in the bone at the beginning of the drilling, wherein the drill bit is configured to drill a hole in the bone when the drill bit tip points toward the bone (fig 15). With respect to claim 2, Gurtowski discloses wherein at least an inner space of the trocar is sterile (paragraph 72). With respect to claim 3, Gurtowski discloses wherein the drill centralizer is sterile (paragraph 72). With respect to claim 4, Gurtowski discloses wherein at least an inner space of the guide is sterile (paragraph 72). With respect to claim 5, Gurtowski discloses wherein the drill bit is sterile (paragraph 72). With respect to claim 6, Gurtowski discloses wherein the sleeve is not sterile (paragraph 72 will not be sterilized until it sterilized as disclosed in paragraph 72). With respect to claim 7, Gurtowski discloses wherein the sleeve is sterile (paragraph 72). With respect to claim 8, Gurtowski discloses wherein an inner diameter of the sleeve is fit to a diameter of the camera (fig 12 and paragraph 66). With respect to claim 14, Gurtowski discloses wherein the guide is further configured to accommodate a locking screw (fig 16, 112) and guide the locking screw to the drill made in the bone and further into the nail hole that is aligned with the drill made in the bone (fig 16).
With respect to claim 15, Gurtowski discloses a method for inserting a locking screw into a nail hole of an intramedullary nail inserted in a medullary canal of a bone, the method comprising: providing a bone with a guide wire inserted into a medullary canal of the bone (fig 2A), after the medullary canal was expanded; providing a system according to claim 1; substantially vertically attaching the trocar to the bone in a location where it is desired to insert a locking screw into a nail hole of an intramedullary nail that is inserted into the intramedullary canal of the bone (fig 12, 102) wherein the trocar remains attached to the bone throughout sequential insertion and removal of multiple different components (figs 12, 13 and 15 below trocar 102 is shown used with each of the drill centralizer, guide and sleeve while remaining in the same position); inserting the drill centralizer into the trocar (fig 13, 108); puncturing a starter hole in the bone with the centralizer tip of the drill centralizer (fig 13); removing the drill centralizer from the trocar while maintaining the trocar attachment to the bone (figures 12-15 shows the trocar 102 remain in position as other components are removed and inserted); inserting the guide (fig 13, 106) into the trocar; inserting the drill bit of the drilling device into the guide (fig 15); drilling a drill in the bone until the medullary canal of the bone (fig 15); removing the drill bit from the guide; removing the guide from the trocar (fig 16 shows the guide and bit and centralizer removed) while maintaining the trocar attachment to the bone (figures 12-15 shows the trocar 102 remain in position as other components are removed and inserted); inserting the sleeve into the trocar (fig 12, 104); inserting the camera into the sleeve; acquiring visual light images of the medullary canal through the drill in the bone with the camera (fig 12); inserting the intramedullary nail into the medullary canal of the bone (fig 12), through the guide wire that is inserted in the medullary canal, until a nail hole of the intramedullary nail is detected by the camera (fig 12); aligning the nail hole of the intramedullary nail with the drill made in the bone (fig 12, and paragraph 55); removing the camera from the sleeve; removing the sleeve from the trocar (fig 16) while maintaining the trocar attachment to the bone (figures 12-15 shows the trocar 102 remain in position as other components are removed and inserted); inserting the guide into the trocar (fig 14); inserting the locking screw into the screw guide; inserting the locking screw into the nail hole of the intramedullary nail that is aligned with the drill in the bone (fig 16); and removing the trocar, and the screw guide from the bone (fig 11). With respect to claim 16, Gurtowski discloses wherein the aligning the nail hole of the intramedullary nail with the drill made in the bone is achieved by rotating the intramedullary nail around a longitudinal axis of the intramedullary nail (fig 12 and paragraph 55). With respect to claim 17, Gurtowski discloses wherein the nail hole of the intramedullary nail is a distal nail hole (fig 11), wherein the locking screw is firstly inserted into the distal nail hole of the intramedullary nail, and then, a locking screw is inserted into a proximal nail hole of the intramedullary nail (paragraph 8).
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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) 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gurtowski (US Pub 2007/0270864) in view of Kristan et al. (US Pub 2009/0177080).
With respect to claim 9, Gurtowski discloses the claimed invention except for wherein the sleeve further comprises at least one notch along an inner part of the sleeve, wherein the at last one notch is configured to fit to an at least one protrusion of the camera, and wherein the at least one notch is configured to circularly fix the camera and prevent rotation of the camera around a longitudinal axis of the camera.
Kristan discloses wherein a sleeve (fig 3, 14) further comprises at least one notch (Fig 3, 28) along an inner part of the sleeve, wherein the at last one notch is configured to fit to an at least one protrusion (see fig 3 below) of the camera, and wherein the at least one notch is configured to circularly fix the camera and prevent rotation of the camera around a longitudinal axis of the camera (fig 3) to ensure the correct position relative to the axis and allow for a very straightforward manipulation (paragraph 28). With respect to claim 10, Kristan discloses wherein the at least one notch is configured to prevent rotation of the camera around a longitudinal axis of a rod or wire to which the camera is attached (fig 3 and paragraph 28). With respect to claim 11, Kristan discloses wherein the at least one notch is configured to allow sliding of the protrusion of the camera along the notch (fig 3 will allow it to slide until it abuts the end of the notch). With respect to claim 12, Kristan discloses wherein the at least one notch runs from an external edge of the sleeve, and ends at a distance from an internal edge of the sleeve (see fig 3 below). With respect to claim 13, Kristan discloses wherein the distance from an internal edge of the sleeve is configured to prevent contact of the camera with the bone and tissues in the vicinity of the bone (fig 3 shows the camera is prevented from reaching the end of the sleeve).
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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 system of Gurtowski to include wherein the sleeve further comprises at least one notch along an inner part of the sleeve, wherein the at last one notch is configured to fit to an at least one protrusion of the camera, and wherein the at least one notch is configured to circularly fix the camera and prevent rotation of the camera around a longitudinal axis of the camera in view of Kristan in order to ensure the correct position relative to the axis and allow for a very straightforward manipulation.
Response to Arguments
Applicant’s arguments, see remarks, filed 10/8/2025, with respect to the objection of the drawings have been fully considered and are persuasive. The objection of the drawings has been withdrawn.
Applicant’s arguments, , with respect to the U.S.C. 112 rejection of claims 1-17 have been fully considered and are persuasive. The U.S.C. 112 rejection of claims 1-17 has been withdrawn.
Applicant's arguments filed 10/8/2025 have been fully considered but they are not persuasive. The applicant argues that Gurtowski does not disclose the trocar remaining in place when multiple different components are inserted and removed therein. The examiner respectfully disagrees. Gurtowski shoes and describes that the trocar 102 is left attached to the to bone from the beginning of the procedure in figure 12 to the end of the procedure in figure 16. As shown above in these steps each of a drill centralizer, a guide, and a sleeve are shown inserted and removed from the trocar while the trocar remains for the next step.
With respect to claims 9-13 the applicant does not individually argue the rejection.
The rejection 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN J COTRONEO whose telephone number is (571)270-7388. The examiner can normally be reached Monday-Friday 9am-5pm 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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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773