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 § 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) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Papangelou et al. (US Publication No. 2016/0166301 A1) in view of Biedermann et al. (US Patent No. 9770277 B2).
Regarding Claim 10, Papangelou discloses an implant (10, Fig. 1) capable of spanning a joint between a first bone and a second bone, the implant comprising: a proximal end (15) configured to reside in the first bone; a distal end (17) comprising threads (25) configured to reside in the second bone distal to the first bone in response to rotation of the implant about an axis of rotation (A) (Fig. 1); an axis (A) extending between the proximal end and the distal end (Fig. 1); an inner cannula (18) extending from the proximal end to the distal end (Fig. 2), and an exterior surface extending from the proximal end to the distal end (surface shown in Fig. 1), the cannulation (18) accepts a guide wire [0041]; and wherein the proximal end (15) further comprises a screw head (14) having the same diameter as a major diameter of the threads (D2, Fig. 2).
Papangelou shows the inner cannula (18) in Figure 2 but does not show said cannula comprising a first diameter at the proximal end and the distal end being smaller than and a second diameter in an intermediate portion between the proximal end and the distal end.
Biedermann discloses an implant (Fig. 2) in the analogous art of bone screws comprising an inner cannula comprising a first diameter at the proximal end and the distal end and a second diameter in an intermediate portion between the proximal end and the distal end, wherein the second diameter is larger than the first diameter (see below). The first diameter is fully capable of accepting a guide wire (col. 4; ln. 40-42) and the second diameter is fully capable of accepting a larger graft material (100 shown in Fig. 8d).
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It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the cannula of Papangelou to have smaller diameters at the ends and a larger diameter in the intermediate section as taught by Biedermann in order to use a known inner cannula configuration in the art which would predictably allow for guide wire passage as well as bone ingrowth.
Regarding Claim 11, Papangelou discloses the implant comprises an axis (A, Fig 2) extending between the proximal end and the distal end, an exterior surface extending from the proximal end to the distal end (shown in Fig. 1), the exterior surface comprising a first recess formed therein (see figure below), the first recess comprising an undercut such that the first recess has a first perimeter at an exterior of the first recess and a second - greater- perimeter, at an interior of the first recess, wherein the interior is closer to the axis than the exterior (shown below).
Regarding Claim 12, that recess depth is less than the radial distance between the inner cannula and exterior (shown below as not extending through the whole thickness of the implant wall).
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Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Papangelou et al. (US Publication No. 2016/0166301 A1) in view of Robbins (US Patent No. 11553953 B1).
Regarding Claim 17, Papangelou discloses an implant (10, Fig. 1) capable of spanning a joint between a first bone and a second bone, the implant comprising: a proximal end (15) configured to reside in the first bone; a distal end (17) comprising threads (25) configured to reside in the second bone distal to the first bone in response to rotation of the implant about an axis of rotation (A) (Fig. 1); an axis (A) extending between the proximal end and the distal end (Fig. 1); an inner cannula (18) extending from the proximal end to the distal end (Fig. 2), and an exterior surface extending from the proximal end to the distal end (surface shown in Fig. 1), a first recess formed therein (see figure below), the first recess comprising an undercut such that the first recess has a first perimeter at an exterior of the first recess and a second - greater- perimeter, at an interior of the first recess, wherein the interior is closer to the axis than the exterior (shown below), that recess depth is less than the radial distance between the inner cannula and exterior (shown below as not extending through the whole thickness of the implant wall).
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However, Papangelou is silent to a cutting flute extending along the distal end interrupting both a major and minor diameter of the threads.
Robbins discloses a bone screw with a distal end having a cutting flute (32) in the same field of endeavor (see Fig. 8), wherein the flute (32) interrupts both the major and minor diameter of the threads (26) (Fig. 1) for the purpose of allowing for bone shear, harvesting and drawing of bone material proximally (col. 6; ln. 40-50).
It would have been obvious to one having ordinary skill in the art before the effective filing date to provide the distal end of the screw of Papangelou with a cutting flute that interrupts both the major and minor thread diameter as taught by Robbins in order to allow for bone shear, harvesting and drawing of bone material proximally.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Papangelou et al. (US Publication No. 2016/0166301 A1) in view of Robbins (US Patent No. 11553953 B1) in further view of Biedermann et al. (US Patent No. 9770277 B2).
Papangelou in view of Robbins discloses the implant of claim 17 as described in the rejection above. Papangelou shows the inner cannula (18) in Figure 2 but does not show said cannula comprising a first diameter at the proximal end and the distal end being smaller than and a second diameter in an intermediate portion between the proximal end and the distal end.
Biedermann discloses an implant (Fig. 2) in the analogous art of bone screws comprising an inner cannula comprising a first diameter at the proximal end and the distal end and a second diameter in an intermediate portion between the proximal end and the distal end, wherein the second diameter is larger than the first diameter (see below). The first diameter is fully capable of accepting a guide wire (col. 4; ln. 40-42) and the second diameter is fully capable of accepting a larger graft material (100 shown in Fig. 8d).
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It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the cannula of Papangelou in view of Robbins to have smaller diameters at the ends and a larger diameter in the intermediate section as taught by Biedermann in order to use a known inner cannula configuration in the art which would predictably allow for guide wire passage as well as bone ingrowth.
Allowable Subject Matter
Claims 13-16, 19-22 are 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.
Claims 1-9 are allowed.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-22 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 JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773