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 .
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 20 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 11,980,372. This is a statutory double patenting rejection.
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.
Claim 7 is 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 7 recites the limitation "the threaded attachment lumen" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
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. 2013/0060253 to Couture 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 moveable 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 coupling structure, and comprises a threaded rod disposed within and threadably coupled with the threaded attachment lumen.
Couture discloses an osteotomy device (10, Fig. 1, [0039]) wherein a rod (60) is rotatably associated with the coupling structure (16, [0055]). The rod comprises a threaded rod (64) disposed within and threadably coupled with the threaded attachment lumen (72, Fig. 5, [0055]) in order to allow for controlled translation and adjustment of the cutting guide [0055].
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 Couture 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. 2013/0060253 to Couture 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 Couture 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 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 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 Couture 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. 2013/0060253 to Couture 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 moveable 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 moveable 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 coupling structure, and comprises a threaded rod disposed within and threadably coupled with the threaded attachment lumen.
Couture discloses an osteotomy device (10, Fig. 1, [0039]) wherein a rod (60) is rotatably associated with the coupling structure (16, [0055]). The rod comprises a threaded rod (64) disposed within and threadably coupled with the threaded attachment lumen (72, Fig. 5, [0055]) in order to allow for controlled translation and adjustment of the cutting guide [0055].
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 Couture 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. 2013/0060253 to Couture 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, Couture, 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 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 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, Couture, and Dayton with the transposition modification of Lam in order to allow for controlled translation and adjustment of the cutting guide..
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775