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 § 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 10-13 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 10 claims a “connection shaft,” independent claim 9 as amended now claims ”a connection shaft assembly.” It is unclear if the connection shaft is part of the connection shaft assembly. Claim 10 should be amended to read “the connection shaft assembly.”
Claim 11 claims “a drill aiming arm and drill sleeve,” independent claim 9 as amended also claims a “drill aiming arm and drill sleeve.” It is unclear if claim 11 is introducing a second arm and sleeve or referring back to the arm and sleeve now claimed in claim 9. Claim 11 should be amended to “the drill aiming arm and drill sleeve.”
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, 7, 8, and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US Pub 2016/0374738) in view of Dacosta et al. (US Pub 2015/0359580).
With respect to claim 1, Smith discloses a method of stabilizing a bone fracture (see figures 7A, 10A,B, 12A and 25B below), the method comprising: positioning a bone plate against an exterior surface of a long bone (fig 7A); securing the bone plate to the bone by attaching a first set of fasteners through the bone plate while avoiding an exclusionary zone intended to later receive an intramedullary nail (fig 9, 404b and paragraph 63); inserting the intramedullary nail into a medullary canal of the bone with a nail insertion handle (fig 8B, 608) due to access provided by the exclusionary zone (fig 10A); attaching a nail aiming arm (fig 8B, 806) to the nail insertion handle, the nail insertion handle having an end support with targeted hole openings that align to the bone plate (paragraph 70); and inserting a second set of fasteners (Fig 12A, 1206 and fasteners in fig 25B, 1002, 1004)) through the targeted hole openings (fig 12A, 824 and holes next to 824) in the nail aiming arm into the bone plate and the intramedullary nail, thereby interlocking the bone plate and the intramedullary nail together (fig 14A). With respect to claim 7, Smith discloses wherein the exclusionary zone is identified on a surface of the plate (shown as an indented area). With respect to claim 8, Smith discloses wherein the exclusionary zone includes a rectangle (see fig 7A below, a rectangle is formed by on the surface by the points where the plate changes from straight to curved) delineating fastener openings through the bone plate nominally pointed toward the intramedullary nail.
With respect to claim 16, Smith discloses method of stabilizing a bone fracture (see figures 7A, 10A,B and 12A below), the method comprising: obtaining a bone stabilization implant comprising an intramedullary nail (fig 10, 610), a bone plate (fig 7A, 102), and a plurality of fasteners (fig 10A and 12A) configured to extend through the bone plate, through the intramedullary nail, or through both the bone plate and the intramedullary nail; and selecting a nail first or plate first workflow depending on fracture type and location (plate first approach shown), wherein the nail first workflow includes inserting the intramedullary nail into the medullary canal first and subsequently attaching the bone plate to an exterior surface of the bone, and wherein the plate first workflow includes attaching the bone plate to the exterior surface of the bone first and subsequently inserting the intramedullary nail into the medullary canal of the bone (fig7A-12A). With respect to claim 17, Smith discloses wherein the plate identifies an exclusionary zone such that when selecting the plate first workflow, fasteners are not entered into the exclusionary zone, which is intended to later receive the intramedullary nail (See fig 7A below). With respect to claim 18, Smith discloses wherein the plurality of fasteners include a locking screw that threads into both the bone plate and the intramedullary nail (Fig 12A, 1206), a locking screw that threads into the bone plate only (fig 10A screws), a headed locking screw (fig 12A, 1204) that threads into the nail only, or a non-locking screw that does not lock to the bone plate or the intramedullary nail (paragraph 53 can have non-locking screws). With respect to claim 19, Smith discloses further comprising interlocking a distal end of the bone plate and the intramedullary nail together with one set of fasteners and interlocking a proximal end of the bone plate and the intramedullary nail together with another set of fasteners (fig 25A shows screws capable of being inserted in 2502 and 2504, paragraph 104). With respect to claim 20, Smith discloses further comprising adjusting a stiffness of the bone stabilization implant by varying a number, type, or location of fasteners (paragraph 79).
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With respect to claims 1 and 16, Smith discloses the claimed invention except for the method of drilling an entry portal for the intramedullary nail into the long bone by passing a drill bit through a drill sleeve of a drill aiming arm, the drill aiming arm configured to be coupled to a connection shaft assembly configured to be coupled to the bone plate, wherein the connection shaft assembly is configured to control an orientation of the drill aiming arm and inserting the nail through the entry port.
Dacosta discloses drilling an entry portal for the intramedullary nail into the long bone (fig 19, 124) by passing a drill bit (paragraph 42) through a drill sleeve (fig 8, 26) of a drill aiming arm (fig 8, 20), the drill aiming arm configured to be coupled to a connection shaft assembly (fig 8, 30) configured to be coupled to the bone plate (fig 8, 80), wherein the connection shaft assembly is configured to control an orientation of the drill aiming arm (paragraph 42, hold guide to the plate in the desired position) and inserting the nail through the entry port (paragraph 42) to allow for accurate insertion (paragraph 44).
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 method of Smith to include drilling an entry portal for the intramedullary nail into the long bone by passing a drill bit through a drill sleeve of a drill aiming arm, the drill aiming arm configured to be coupled to a connection shaft assembly configured to be coupled to the bone plate, wherein the connection shaft assembly is configured to control an orientation of the drill aiming arm in view of Dacosta to allow for accurate insertion.
Claim(s) 2-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Dacosta as applied to claim 1 above, and further in view of Machamer et al. (US Pub 2018/0140310).
With respect to claims 2, Smith in view of Dacosta discloses the claimed invention with a proximal aiming unitary with the nail aiming arm (two arms of 606) and does not disclose a separate arm wherein the method includes attaching a proximal aiming arm to the nail aiming arm.
Machamer discloses attaching a proximal aiming arm (fig 8, 560) to a nail aiming arm (fig 7, 540) to allow for adding an impact shaft to the nail aiming arm to allow for insertion (paragraphs 27 and 28). With respect to claim 2, Machamer discloses the proximal aiming arm is attached with one or more connection pins (fig 8, 574, 576).
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 method of Smith to include attaching a proximal aiming arm to the nail aiming arm in view of Machamer in order to allow for adding an impact shaft to the nail aiming arm to allow for insertion. With respect to claim 3, Smith in view of Dacosta in view of Machamer discloses further comprising after attaching the proximal aiming arm to the nail aiming arm, inserting another set of fasteners through the guide hole openings in the proximal aiming arm into the bone plate and the intramedullary nail, thereby interlocking the bone plate and intramedullary nail together (fig 25B of smith fasteners in 1002 and 1004). With respect to claim 4, Smith in view of Dacosta in view of Machamer discloses further comprising after attaching the proximal aiming arm to the nail aiming arm, inserting another set of fasteners through the guide hole openings in the proximal aiming arm and into the bone plate only (fasteners in 7B lower right). With respect to claim 5, Smith in view of Dacosta in view of Machamer discloses wherein some of the fasteners positioned through the bone plate only target a neck and head of the long bone and some of the fasteners positioned through the bone plate only target a shaft of the long bone while avoiding the intramedullary nail (Fig 10B where that is no opening in the nail under 1002 a fastener would be in the shaft and in the bone plate without being in the nail). With respect to claim 6, Smith in view of Dacosta in view of Machamer discloses further comprising after attaching the proximal aiming arm to the nail aiming arm, inserting a single fastener through one of the targeted hole openings in the nail aiming arm and into the intramedullary nail only (fig 12A, 1202).
Claim(s) 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US Pub 2016/0374738) in view of Dacosta et al. (US Pub 2015/0359580) and in view of Machamer et al. (US Pub 2018/0140310).
With respect to claim 9, Smith discloses a method of stabilizing a bone fracture (See figures 7A, 10A,B, 12A and 25B above), the method comprising: positioning a bone plate against an exterior surface of a long bone (fig 7A); securing the bone plate to the bone by attaching a first set of fasteners through the bone plate (fig 10A and paragraph 63) while avoiding an exclusionary zone intended to later receive an intramedullary nail (see fig 7A above); inserting the intramedullary nail into a medullary canal of the bone with a nail insertion handle due to access provided by the exclusionary zone (fig 10A); attaching a nail aiming arm (fig 10A, 606) to the nail insertion handle (fig 10A, 608), the nail insertion handle having an end support with targeted hole openings (fig 10B, 822, 820) that align to the bone plate; inserting a second set of fasteners through the targeted hole openings in the nail aiming arm into the bone plate and the intramedullary nail (fig 12A, 1206 and fig 25B a screw in 1002 or 1004), thereby interlocking the bone plate and the intramedullary nail together; the aiming arm has a proximal aiming arm with guide opens (2nd arm of 606); the proximal aiming arm defining a plurality of guide hole openings (openings in 606) inserting a third set of fasteners through the guide hole openings in the proximal aiming arm into the bone plate and the intramedullary nail (fig 25B screws in 1002); inserting a fourth set of fasteners through the guide hole openings in the proximal aiming arm and into the bone plate only (screws in the bottom right of 7B); inserting a fifth set of fasteners through the guide hole openings in the proximal aiming arm and into the bone plate only (screws in upper right of fig 7B) and inserting a sixth fastener through one of the targeted hole openings in the nail aiming arm and into the intramedullary nail only (fig 12, 1202). With respect to claim 10, Smith discloses further comprising, after securing the bone plate to the bone, attaching a connection shaft to the bone plate (Fig 10B, 1002). With respect to claim 13, Smith discloses further comprising, prior to positioning the bone plate, attaching the connection shaft to the bone plate to install the bone plate (fig 7C, 402). With respect to claim 14, Smith discloses further comprising, prior to positioning the bone plate, reducing the bone fracture to restore length, alignment, and rotation of the bone (fig 7C shows a restored bone with a reduced fracture). With respect to claim 15, Smith discloses wherein the bone is a femur, the intramedullary nail is inserted into a distal end of the femur, and the bone plate sits on a lateral surface of the femur such that a distal end of the bone plate secures the distal end of the femur, and a proximal end of the bone plate secures a head of the femur (paragraph 39).
With respect to claim 9, Smith discloses the claimed invention except for the method of drilling an entry portal for the intramedullary nail into the long bone by passing a drill bit through a drill sleeve of a drill aiming arm, the drill aiming arm configured to be coupled to a connection shaft assembly configured to be coupled to the bone plate, wherein the connection shaft assembly is configured to control an orientation of the drill aiming arm and inserting the nail through the entry port and Smith discloses the claimed invention with a proximal aiming unitary with the nail aiming arm (two arms of 606) and does not disclose a separate arm wherein the method includes attaching a proximal aiming arm to the nail aiming arm.
Dacosta discloses drilling an entry portal for the intramedullary nail into the long bone (fig 19, 124) by passing a drill bit (paragraph 42) through a drill sleeve (fig 8, 26) of a drill aiming arm (fig 8, 20), the drill aiming arm configured to be coupled to a connection shaft assembly (fig 8, 30) configured to be coupled to the bone plate (fig 8, 80), wherein the connection shaft assembly is configured to control an orientation of the drill aiming arm (paragraph 42, hold guide to the plate in the desired position) and inserting the nail through the entry port (paragraph 42) to allow for accurate insertion (paragraph 44). With respect to claim 11, Dacosta discloses further comprising, after attaching the connection shaft to the bone plate, attaching a drill aiming arm and drill sleeve to the connection shaft, wherein the drill sleeve is aligned along a trajectory (fig 19 and paragraph 42). With respect to claim 11, Dacosta discloses further comprising, after attaching the drill aiming arm and drill sleeve to the connection shaft, drilling an entry portal into the bone by passing a drill bit through the drill sleeve (paragraph 42).
Machamer discloses attaching a proximal aiming arm (fig 8, 560) to a nail aiming arm (fig 7, 540) to allow for adding an impact shaft to the nail aiming arm to allow for insertion (paragraphs 27 and 28).
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 method of Smith to include drilling an entry portal for the intramedullary nail into the long bone by passing a drill bit through a drill sleeve of a drill aiming arm, the drill aiming arm configured to be coupled to a connection shaft assembly configured to be coupled to the bone plate, wherein the connection shaft assembly is configured to control an orientation of the drill aiming arm in view of Dacosta to allow for accurate insertion 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 method of Smith to include attaching a proximal aiming arm to the nail aiming arm in view of Machamer in order to allow for adding an impact shaft to the nail aiming arm to allow for insertion.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 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.
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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773