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) 1-2, 4-5, 7-11, 13-15, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCormick (US Patent Pub. 20140066995A1) in view of Schafer et al (US Patent Pub. 20220273348A1).
McCormick recites a bone fusion plate capable of treating hallux valgus/a lateral shift osteotomy buttress plate. Specifically in regards to claim 1 and 14, McCormick recites a plate portion (portion of 100 having 112/114) comprising a lower, distal surface; the plate portion (portion of 100 having 112/114) having a planar member having a lower, distal surface that is adapted to be attached to the surface of a metatarsal head; and a buttress (portion of 100 having 126) comprising a proximal surface wherein the buttress (portion of 100 having 126) is a thicker portion of the bone fusion plate (100) and includes a proximal surface configured to be attached to the proximal bone surface of a first metatarsal bone; and wherein the distal and proximal surfaces share an intervening buttress angle (theta) configured to fixate the first metatarsal bone and the metatarsal head (The recitation of the plate being affixed to a metatarsal bone is considered a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the current case the bone plate 100 is fully capable of buttressing against the metatarsal bone.) (Fig. 1-3; and Para. [0039]-[0045]). The proximal surface comprises a cut guide configured to guide cutting the first metatarsal bone (Applicant demonstrates the cutting guide as being merely the proximal surface as shown in Fig. 9a of the specification as originally filed. In the instant case the proximal surface of the buttress of the plate of McCormick can also serve as a cutting guide in a similar manner as applicant’s invention.) (Fig. 1-3). However, the reference is silent as to a buttress angle in the range of 70-110 degrees or wherein the proximal openings having a threaded countersink.
Schafer recites a bone fusion plate for treating hallux valgus/a lateral shift osteotomy plate. Specifically, Schafer in regards to claim 1 and 14, recites a bone fusion plate having distal and proximal surfaces which share an intervening buttress angle for fixating the 1st metatarsal bone (120) and the metatarsal head (116) (Fig. 3-4, and Para. [0006], [0023],[0025],[0028]-[0029]). Schafer regards to claims 4 and 19, recites wherein any one or more of the one or more proximal screw holes (110) includes a threaded countersink for threadably engaging a head portion of a proximal bone screw (114) (As shown in Fig. 1-2, the apertures 110 are countersunk.) (Fig. 1-6; and Para. [0033]-[0034]). In regards to claim 13 and 17, Schafer recites wherein the buttress angle ranges between about 70 degrees and about 110 degrees (Fig. 1-6; and Para. [0006],[0025]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the plate and proximal openings of McCormick to have a buttress angle in the range of 70-110 degrees and threaded countersink openings as taught in Schafer in order to allow for rotational control and easier correction and adjustment; and, the plate and its extensions provide for control and placement of the metatarsal head in the corrected construct after performance of an osteotomy (Para. [0006]).
In regards to claims 2 and 18, McCormick recites wherein the buttress (portion of 100 having 126) includes one or more proximal screw holes (126) configured to receive bone screws (127) for attaching the buttress (portion of 100 having 126) to a proximal bone surface of a metatarsal bone (Fig. 1-2; and Para. [0040]).
In regards to claim 5, McCormick recites wherein the one or more proximal screw holes (126) are disposed in the buttress (portion of 100 having 126) at a proximal screw angle with respect to the plate portion (portion of 100 having 112/114) (Fig. 1 and 3).
In regards to claim 7, McCormick recites wherein the plate portion (portion of plate having 112/114) includes one or more distal screw holes (112/114) configured to receive bone screws (115) for attaching the plate portion to a metatarsal head (Fig. 1-3).
In regards to claim 8, McCormick recites wherein the one or more distal screw holes (112/114) are positioned at different distances from the buttress (portion with 126) (Fig. 1-3).
In regards to claim 9, McCormick recites wherein any one or more of the one or more distal screw holes (112) includes a threaded countersink (112) for threadably engaging a head portion of a distal bone screw (115) (As shown in Fig. 1-3 the non-locking screw hole 126 is oriented at an angle .theta. of about 45 degrees from the locking screw hole 112.) (Fig. 1-3; and Para. [0040]).
In regards to claim 10, McCormick recites wherein the proximal surface is configured to be attached to a proximal bone surface formed by cutting a metatarsal bone and laterally shifting the metatarsal head (The recitation of the plate being affixed to a metatarsal bone is considered a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the current case the bone plate 100 is fully capable of buttressing against the metatarsal bone.) (Fig. 1-3; and Para. [0039]-[0045]).
In regards to claim 11 and 15, McCormick recites wherein the proximal and distal surfaces share an intervening buttress angle suitable for fixating the metatarsal bone and the metatarsal head (Fig. 3; and Para. [0040]).
Claim(s) 3, 6, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCormick in view of Schafer as applied to claims 2 and 18 above, and further in view of DaCosta et al (US Patent Pub. 20170325859A1).
McCormick in view of Schafer discloses a buttress plate having a plate portion with a distal surface and distal openings and a buttress portion with a proximal surface and proximal openings. However, the reference is silent as to the proximal openings having a variable angle.
DaCosta recites a bone fusion plate for treating hallux valgus/a lateral shift osteotomy plate. Specifically, DaCosta recites a plate (400) having a proximal openings (432) and a plate portion (410/420) having distal openings (412/422) (Fig. 30-40; and Para. [0089]-[0093]). In regards to claims 3, 6, and 20, DaCosta recites wherein any one or more of the one or more proximal screw holes (432) includes a conical relief adapted to allow for variable screw angulation for a range of osteotomy shifts (Fig. 39-40; and Para. [0047], [0098]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the opening (126) of McCormick to be a variable angle opening as taught in DaCosta in order to allow for the fastener to be inserted in an off-axis position (Para. [0068]).
Response to Arguments
Applicant’s amendments filed on 2/28/26 have overcome the previous 101 rejections which are now withdrawn.
Applicant’s arguments filed on 2/28/26 have been fully considered but they are not persuasive. Applicant has now amended the claims to recite that the proximal surface of the plate comprises a cut guide configured to guide the cutting of the metatarsal (Remarks Pg. 6) which applicant argues is not shown in the cited references. However, applicant demonstrates the cutting guide as being merely the proximal surface as shown in Fig. 9a and Para. [0006] and [0018] of the specification as originally filed. In the instant case, the proximal surface of the buttress of the plate of McCormick is also capable of serving as a cutting guide in a similar manner as applicant’s invention (see Fig. 1-3). Therefore, the continued rejection of the claims is maintained.
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 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