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 .
Response to Arguments
Applicant’s arguments, filed April 21, 2026, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made. Please direct attention to rejection below, specifically reference McGinley regarding the amended limitations of wherein rotation of the rod urges the movable cutting guide longitudinally along a length of the rod.
Allowable Subject Matter
Claim 20 is allowable over the prior art.
The following is a statement of reasons for the indication of allowable subject matter: The prior art fails to teach or disclose the method steps including but not limited to inserting a first anchoring pin through the transverse slot and into the target bone, inserting a second anchoring pin through an opening defined in the bone attachment structure and into the target bone, making a desired cut in the target bone with a saw blade positioned against the movable cutting guide, resulting in a base bone and a cut bone, inserting a transposition mechanism through the movable cutting guide and into the cut bone, urging the cut bone distally from the base bone by rotating the rod associated with the guide coupling structure, urging the cut bone laterally by actuating the transposition mechanism, and urging the cut bone proximally into contact with the base bone by rotating the rod associated with the guide coupling structure.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2020/0060690 to Woodard et al. in view of U.S. Patent Pub. No. 2014/0188236 to McGinley et al.
As to Claim 1, Woodard discloses an osteotomy device (Fig. 3A, [0003]). The device comprises a device body (Fig. 3A) comprising a bone attachment structure (100, [0027]), and a guide coupling structure (200) comprising a rod (rail 170, [0034]), a movable cutting guide (300) threadably coupled (via set screw 330) to the rod [0039], and a slot body (400) removably attachable to the device body [0042-0044], wherein the slot body comprises a transverse slot (410) defined within the slot body (Fig. 3D, [0043]).
As to Claim 5, Woodard discloses an osteotomy device wherein the movable cutting guide (300) comprises a proximal guide edge (310, [0039], Fig. 3C).
As to Claim 6, Woodard discloses an osteotomy device wherein the movable cutting guide (300) comprises an attachment body (335), wherein the attachment body comprises a threaded attachment lumen (340, Fig. 3C, [0039]).
As to Claims 1 and 5-7, Woodard discloses the claimed invention except for wherein the rod is rotatably associated with the guide coupling structure, wherein rotation of the rod urges the movable cutting guide, and the rod comprises a threaded rod disposed within and threadably coupled with the threaded attachment lumen.
McGinley discloses an osteotomy device (100, Fig. 1, [0027]) wherein a rod (113) is rotatably associated with a guide coupling structure (110, [0029]). Rotation of the rod (113) urges the movable cutting guide (120). The rod comprises a threaded rod (113) disposed within and threadably coupled with the threaded attachment lumen (within 110, Fig. 1, [0029]) in order to allow for controlled translation and adjustment of the cutting guide [0029].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the osteotomy device of Woodard with the rotatable threaded rod modification of McGinley in order to allow for controlled translation and adjustment of the cutting guide.
Claims 2-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2020/0060690 to Woodard et al. in view of U.S. Patent Pub. No. 2014/0188236 to McGinley et al.in view of U.S. Patent Pub. No. 2021/0259749 to Lam et al.
As to Claims 2-4 and 8, Woodard and McGinley disclose the claimed invention except for wherein the movable cutting guide comprises a transposition mechanism threadably coupled thereto, wherein the transposition mechanism comprises a rotatable elongate body and a distal plate attached to a distal end of the threaded rotatable elongate body, wherein the distal plate is a rotatable circular plate, wherein the rotatable elongate body is a threaded rotatable elongate body disposed through a first threaded guide lumen defined in the movable cutting guide, and a second opening defined in the movable cutting guide, the second opening configured to receive an attachment pin.
Lam discloses an osteotomy device (Fig. 35) wherein a movable cutting guide (214) comprises a transposition mechanism (250) threadably coupled thereto [0166-0167], wherein the transposition mechanism comprises a rotatable elongate body (257) and a distal plate (255) attached to a distal end of the threaded rotatable elongate body (Fig. 35, [0167-0168]), wherein the distal plate is a rotatable circular plate [0167-0168], wherein the rotatable elongate body is a threaded rotatable elongate body disposed through a first threaded guide lumen defined in the movable cutting guide (described in [0166-0168]). A second opening (245) is defined in the movable cutting guide (Fig. 34), the second opening configured to receive an attachment pin (247, [0165]) in order to provide additional adjustable means for securing the cutting guide to the target bone [0166-0167].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the osteotomy device of Woodard and McGinley with the transposition modification of Lam in order to allow for controlled translation and adjustment of the cutting guide.
Claims 9, 13-15, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2020/0060690 to Woodard et al. in view of U.S. Patent Pub. No. 2014/0188236 to McGinley et al. in view of U.S. Patent Pub. No. 2017/0014143 to Dayton et al.
As to Claim 9, Woodard discloses an osteotomy device (Fig. 3A, [0003]). The device comprises a guide device having device body (Fig. 3A) comprising a bone attachment structure (100, [0027]), and a guide coupling structure (200) comprising a rod (rail 170, [0034]), a movable cutting guide (300) threadably coupled (via set screw 330) to the rod [0039], and a slot body (400) removably attachable to the device body [0042-0044], wherein the slot body comprises a transverse slot (410) defined within the slot body (Fig. 3D, [0043]).
As to Claim 13, Woodard discloses an osteotomy device wherein the movable cutting guide (300) comprises a proximal guide edge (310, [0039], Fig. 3C).
As to Claim 14, Woodard discloses an osteotomy device wherein the movable cutting guide (300) comprises an attachment body (335), wherein the attachment body comprises a threaded attachment lumen (340, Fig. 3C, [0039]).
As to Claim 17, Woodard discloses an osteotomy device wherein the bone attachment structure (100) comprises at least two fixation screw openings (140) defined therein [0033]. Woodard discloses a bone contacting structure (315) having a curved face configured to be contactable with the target bone [0041].
As to Claim 18, Woodard discloses an osteotomy device wherein the moveable cutting guide (300) is movable along a path substantially parallel with a length of the target bone (from A to B, Fig. 1A, [0028]).
As to Claims 9, 13-15, 17 and 18, Woodard discloses the claimed invention except for a fixation plate attachable to a portion of the target bone after removal of the slot body, wherein the rod is rotatably associated with the guide coupling structure, wherein rotation of the rod urges the movable cutting guide longitudinally along a length of the rod, and comprises a threaded rod disposed within and threadably coupled with the threaded attachment lumen.
McGinley discloses an osteotomy device (100, Fig. 1, [0027]) wherein a rod (113) is rotatably associated with a guide coupling structure (110, [0029]). Rotation of the rod (113) urges the movable cutting guide (120) longitudinally along a length of the rod [0029]. The rod comprises a threaded rod (113) disposed within and threadably coupled with the threaded attachment lumen (within 110, Fig. 1, [0029]) in order to allow for controlled translation and adjustment of the cutting guide [0029].
Dayton discloses an osteotomy device including a fixation plate (460) attachable to a portion of the target bone after removal of the slot body (Fig. 13, [0035]) in order to allow for fixation of the target bones after the osteotomy is performed [0035].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the osteotomy device of Woodard with the rod modification of McGinley in order to allow for controlled translation and adjustment of the cutting guide, and with the fixation plate modification of Dayton in order to allow for fixation of the target bones after the osteotomy is performed.
Claims 10-12, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2020/0060690 to Woodard et al. in view of U.S. Patent Pub. No. 2014/0188236 to McGinley et al. in view of U.S. Patent Pub. No. 2017/0014143 to Dayton et al. in view of U.S. Patent Pub. No. 2021/0259749 to Lam et al.
As to Claims 10-12, 16, and 19, Woodard, McGinley, and Dayton disclose the claimed invention except for wherein the movable cutting guide comprises a transposition mechanism threadably coupled thereto, wherein the transposition mechanism comprises a rotatable elongate body and a distal plate attached to a distal end of the threaded rotatable elongate body, wherein the distal plate is a rotatable circular plate, wherein the rotatable elongate body is a threaded rotatable elongate body disposed through a first threaded guide lumen defined in the movable cutting guide, and a second opening defined in the movable cutting guide, the second opening configured to receive an attachment pin, and wherein rotation of the transposition rod causes transverse movement of the transposition rod in relation to a longitudinal axis of the target bone.
Lam discloses an osteotomy device (Fig. 35) wherein a movable cutting guide (214) comprises a transposition mechanism (250) threadably coupled thereto [0166-0167], wherein the transposition mechanism comprises a rotatable elongate body (257) and a distal plate (255) attached to a distal end of the threaded rotatable elongate body (Fig. 35, [0167-0168]), wherein the distal plate is a rotatable circular plate [0167-0168], wherein the rotatable elongate body is a threaded rotatable elongate body disposed through a first threaded guide lumen defined in the movable cutting guide (described in [0166-0168]). A second opening (245) is defined in the movable cutting guide (Fig. 34), the second opening configured to receive an attachment pin (247, [0165]). Rotation of the transposition rod (257) causes transverse movement of the transposition rod in relation to a longitudinal axis of the target bone [0167-0168] in order to provide additional adjustable means for securing the cutting guide to the target bone [0166-0167].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the osteotomy device of Woodard, McGinley, and Dayton with the transposition modification of Lam in order to allow for controlled translation and adjustment of the cutting guide.
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 CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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