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 and 6 is/are rejected under 35 U.S.C. 103 as being obvious over Matityahu (US Patent Pub. 20080188852A1).
Matityahu recites a system for fixation or fusion of bone segments in an extremity bone. Specifically in regards to claim 1, Matityahu recites the system comprising: one or more drill guides (drilling sleeve 68, Para. [0032]), the one or more drill guides having a tip configured to be couple one or more through-holes (45) in a bone plate (44) and a cannulation that extends from the tip through the drill guide (Matityahu recites drilling sleeves, may be operably attached to the bone plate receptor 66 to facilitate or guide the drilling of target openings in the bone portion 34 for attachment of bone screws 50 to the bone pieces.) (Fig. 1-5; and Para. [0032]). Matityahu also recites a targeting instrument (46) having a platform and a guide body (body of 46) and a stabilizing guide channel (channel for 64) for receiving a stabilizing wire, the guide body (body of 46) having one or more guide channels (56) with a size and shape configured to receive the one or more drill guides (Fig. 1-5; and Para. [0032]).
In regards to claim 6, Matityahu recites wherein the one more guide channels (56) of the guide body (body of 46) is sized and shaped to permit a bone anchor is pass completely therethrough (Fig. 1-5; and Para. [0032]).
Claim Rejections - 35 USC § 103
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, 4-6, and 11 is/are rejected under 35 U.S.C. 103 as being obvious over Lueth et al (US Patent Pub. 20180289402A1).
Lueth recites a system for fixation or fusion of bone segments in an extremity bone. Specifically in regards to claim 1, Lueth recites the system comprising: one or more drill guides (270), the one or more drill guides (270) having a tip configured to be against one or more through-holes (62) in a bone plate (10) and a cannulation that extends from the tip through the drill guide (Fig. 20; and Para. [0129]). Lueth also recites a targeting instrument having a platform (210/310) and a guide body and a stabilizing guide channel (channel for 280) for receiving a stabilizing wire, the guide body having one or more guide channels (362/262) with a size and shape configured to receive the one or more drill guides (270) (Fig. 20; and Para. [0128]-[0130]). However, this embodiment of Lueth is silent as to the guide coupling with one or more through holes on a plate. Lueth in the embodiment shown in Fig. 49-50, discloses a series of drill guides (472) that pass through one ore more channels of a targeting instrument (452) and have a tip (476) configured to be coupled to one or more through-holes in a bone plate (10) (Lueth recites sleeve 472 may include a head 474 and a tip 476 configured and dimensioned to fit into the holes 62 of the bone plate.) (Fig. 49-50; and Para. [0152]-[0153]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the guide (270) of Lueth shown in Fig. 20 to have a tip that can be inserted into plate holes as taught in Fig. 49-50 in order to allow the guides to be inserted and held in plate openings (Para. [0153]).
In regards to claim 4, Lueth recites wherein the guide body is a proximal guide body (body of 310) having one or more proximal guide channels (362), and the targeting instrument further comprises a distal guide body (body of 210) having one or more distal guide channels (262) (Fig. 20; and Para. [0128]).
In regards to claim 5, Lueth recites wherein the one or more proximal guide channels (362) extend along a proximal guide axis, and the one or more guide channels (262) extend along a respective distal guide axis that is angled with respect to the proximal guide axis (Fig. 20).
In regards to claim 6, Lueth recites wherein the one more guide channels (262/362) of the guide body (bodies of 210/310) is sized and shaped to permit a bone anchor is pass completely therethrough (Fig. 20; and Para. [0129]-[0130]).
In regards to claim 11, Lueth as recited above recites a system for the fixation or fusion of bone segments. However, the embodiment is silent as to the holes having a shoulder. Lueth in the embodiment shown in Fig. 17 recites wherein the guide body (body of 210) includes a shoulder (counterbore in 262 shown in Fig. 17) configured to contact a proximal-most end of a drill guide (270) to set a distance of the target instrument (210) relative to a bone plate (10) when the targeting instrument (210) is coupled to the bone plate (10) (The counterbore of openings 262 are capable as acting as depth stops for guides inserted therein.) (Fig. 17; and Para. [0122]-[0123]). It would have been obvious to combine the embodiments of Lueth at the time the invention was filed to modify the openings 262 to have shoulders/counterbores in order to have a means to ensure the guide is not inserted too far into place.
Claim(s) 2-3 and 8 is/are rejected under 35 U.S.C. 103 as being obvious over Matityahu in view of Peterson et al (US Patent Pub. 20210100594A1).
Matityahu as recited above recites a system for the fixation or fusion of bone segments comprising one or more drill guides and a targeting instrument. In regard to claims 2 and 8, Matityahu recites an anchor targeter (32) having a base (87) sized and shaped to engage the platform (46), an aiming arm (93) extending and curving from the base (87), an aiming body at a terminal end of the aiming arm (93), and an aiming channel (148/channel through 96) that extends through the aiming body, the aiming channel extending along a targeting axis that is inferior to and does not intersect the platform (46), wherein the anchor targeter (32) is configured to move relative to the platform (46) to align the targeting axis with a desired anchor trajectory (Fig. 1-7; and Para. [0034]-[0039]). However, the reference is silent as to an anchor targeter being rotatably coupled.
Peterson recites a system for the fixation or fusion of bone segments. Specifically in regards to claim 2, Peterson recites an anchor targeter (14) having a base (34) sized and shaped to rotatably engage the platform, an aiming arm (78) extending and curving from the base (34) (Fig. 1-4; and Para. [0022]-[0027]). In regards to claim 8, Peterson recites wherein the instrument (54/56) includes one or more first engagement elements, and the anchor targeter (34/50) include one or more second engagement elements configured to engage the first engagement elements (The arms 34 and 56 move relative to one another by means of a ratchet mechanism 90.) (Fig. 3; and Para. [0026]). It would have been obvious to modify the anchor targeter (32) of Matityahu to be rotatable relative to the platform as taught in Peterson in order to allow for the targeter to move in more degrees of freedom for anchor placement.
In regards to claim 3, Matityahu recites wherein the anchor targeter (32) is engageable to the platform (46) such that it does not rotate (Fig. 1).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being obvious over Matityahu in view of Peterson as applied to claim 8, above and further in view of Pimenta (US Patent Pub. 20130310937A1).
Matityahu in view of Peterson as recited above recites a system for the fixation or fusion of bone segments comprising one or more drill guides and a targeting instrument and rotatable anchor targeter. In regards to claim 9-10, Peterson recites the anchor targeter that is rotatably connected to an instrument (Fig. 3-4). However, the references are silent as to the first and second engagement elements comprising either a pivot post and a guide post while the other comprises a curved ridge.
Pimenta in regards to claim 9-10, recites wherein the one or more first engagement elements comprise a pivot post (post in Fig. 24), a guide post (663) extending from the base and spaced toward an outer edge, and a curved ridge (653) extending from the base (618), wherein the curved ridge (653) curves relative to the pivot post; and wherein the one or more second engagement elements are on the other base portion (625) and include a bore (see Fig. 24) configured to couple to the pivot post, a first slot (670) that receives the curved ridge (653), and a second slot (671) that receives the guide post (663), wherein the second base rotates about the pivot post to adjust its position (Fig. 24; and Para. [0146]-[0147]). It would have been obvious to modify the ratchet (90) of anchor targeter (32) of Matityahu to be a dovetail connection as taught in Pimenta in order to allow the two elements to connect and prevent them from separating from one another within a particular range of relative rotational movement (Para. [0147]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being obvious over Matityahu in view Dacosta et al (US Patent Pub. 20150359580A1).
Matityahu recited above recites a system for the fixation or fusion of bone segments comprising one or more drill guides and a targeting instrument. In regards to claim 12, Matityahu recites a bone plate (44) having one or more proximal through-holes (holes connected to 66, Fig. 2) configured to be positioned adjacent a first bone segment, and one or more distal through-holes (holes in shaft of 44) spaced apart from the one or more proximal through-holes and configured to be positioned adjacent a second bone segment; one or more proximal bone anchors (50) configured to be inserted into the one or more proximal through-holes (holes adjacent 66) of the bone plate and into the first bone segment when the bone plate (44) is in position adjacent the first bone segment; and one or more distal bone anchors (50) configured to be inserted into the one or more distal through-holes (holes in shaft) of the bone plate (44) and into the second bone segment when the bone plate (44) is in position adjacent the second bone segment (Fig. 2; and Para. [0031]). However, the references is silent as to a cross anchor.
Dacosta recites a system for bone fixation and fusion. Specifically in regards to claim 12, Dacosta recites a plate (80) configured for placement on first and second bone segments (84/88), and having proximal and distal through-holes (90/92/94) (Fig. 5-6); and a crossing anchor (50) having a shaft (56) with a proximal end (52) and a distal end (54) spaced from the proximal end (52) along a central axis, wherein proximal end (52) has a proximal beveled surface that is angled with respect to the central axis so that it sits flush with a surface of either the first or second bone segment (84/88), wherein the crossing anchor (50) is configured to span the first and second bone segments (84/88) and be spaced from an inferior surface of the bone plate (80) and a shaft of the one or more proximal/distal bone anchors (100/102) when the bone plate (80) and proximal and distal bone anchors (100/102) are implanted into the bone segments (84/88) (Fig. 2 and 8; and Para. [0035], [0038], [0044]). It would have been obvious to modify the system of Matityahu to have a cross anchor in view of Dacosta in order to allow for the system to compress the two bone fragments together during the healing process.
Allowable Subject Matter
Claim 7 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. The closest art of record is the Matityahu and Lueth references which recite drill guides and targeting instruments attached to a bone plate however, none of the stabilization openings are positioned such that they are not intersecting with the bone plate. Therefore, the claims of the instant application have not been rejected using prior art because none of the references or reasonable combinations thereof could be found which disclose or suggest all of the features of the claims, and there is no reasonable motivation to modify the art of record to have these features. Furthermore, attempting to modify the references to have all the cited limitations would destroy the proposed inventions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775
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