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 § 112(b)
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.
Claims 1-19 are 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 1 recites the limitation "the greatest thickness of the medial cuneiform" in ll. 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the heads" in ll. 2 and “the surface” in ll. 3. There is insufficient antecedent basis for these limitations in this claim.
Claim 5 recites the limitation "the heads" in ll. 2 and “the surface” in ll. 3. There is insufficient antecedent basis for these limitations in this claim.
Regarding claim 7, the phrase “may be” is indefinite.
Claim 12 recites the limitation "the heads" in ll. 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the greatest thickness of the medial cuneiform" in ll. 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the greatest thickness of the medial cuneiform bone" in ll. 7. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 19, the phrase “may be” is indefinite.
Claims 2, 3, 6, 8-11, 14, 15, 17, and 18 are rejected on being dependent to a rejected base claim.
Examiner’s Note
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.
Claim Rejections - 35 USC § 102
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) 1-13 and 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blitz et al. (US 2014/0379036), herein referred to as Blitz.
Regarding claim 1, Bltiz discloses a bone fusion plate (20) (¶9) for fixating a 1st tarsal-metatarsal joint (figures 5A, 5B, 6), comprising an elongate member (figure 2) including a proximal contact surface (24) and a distal contact surface (22), one or more proximal apertures (52) (¶27) for implantation of proximal bone screws into a medial cuneiform bone (12) (¶31 and figures 5A, 5B, 6), one or more distal apertures (46) (¶26) for implantation of distal bone screws into a 1st metatarsal bone (10) (¶32 and figures 5A, 5B, 6), and a medial thickness (¶25 and figure 3A) and a lateral thickness (¶25 and figure 3A) for vertically implanting the proximal bone screws (¶31) toward the greatest thickness of the medial cuneiform (12) (figures 5A, 5B, 6).
Regarding claim 2, Bltiz discloses wherein the proximal contact surface (24) is configured to (i.e. capable of) contact a dorso-medial portion of the medial cuneiform bone (12).
Regarding claim 3, Bltiz discloses wherein the distal contact surface (22) is configured to (i.e. capable of) contact a cortical surface of the 1st metatarsal bone (10).
Regarding claim 4, Bltiz discloses wherein any one or more of the one or more proximal apertures (52) includes a countersink (¶27) for receiving the heads of the proximal bone screws (¶31) below the surface of the bone fusion plate (10) so as to avoid potential tissue irritation (¶25).
Regarding claim 5, Bltiz discloses wherein any one or more of the one or more distal apertures (46) includes a countersink (¶32) for receiving the heads of the distal bone screws (¶32) below the surface of the bone fusion plate (10) so as to avoid potential tissue irritation (¶25).
Regarding claim 6, Bltiz discloses wherein a spacing (figure 2) is disposed between the one or more proximal apertures (52) and the one or more distal apertures (46).
Regarding claim 7, Bltiz discloses wherein the spacing (figure 2) is adapted to (i.e. capable of) position the proximal bone screws away from a cross screw that may be used to treat a Lisfranc injury (considered functional).
Regarding claim 8, Bltiz discloses wherein the proximal contact surface (24) and the distal contact surface (22) share an intervening longitudinal angle with respect to one another (figure 4).
Regarding claim 9, Bltiz discloses wherein the longitudinal angle (¶30) is configured to (i.e. capable of) cause the bone fusion plate (10) to advantageously match cortical surface anatomies of the medial cuneiform (12) and 1st metatarsal (10) bones across the 1st TMT joint (figures 5A, 5B, 6).
Regarding claim 10, Bltiz discloses wherein the elongate member (figure 2) includes a tapered distal tip (26) that is configured to (i.e. capable of) slide under soft tissue during implantation of the bone fusion plate (10) across the 1st TMT joint (figures 5A, 5B, 6).
Regarding claim 11, Bltiz discloses wherein the tapered distal tip (26) is configured to (i.e. capable of) facilitate using a minimal incision length during implantation of the bone fusion plate (¶25).
Regarding claim 12, Bltiz discloses wherein the medial thickness (¶25 and figure 3A) is configured to (i.e. capable of) hide the heads of proximal bone screws so as to avoid any potential tissue irritation that might otherwise occur (¶25).
Regarding claim 13, Bltiz discloses wherein medial thickness (¶25 and figure 3A) and the lateral thickness (¶25 and figure 3A) are configured to (i.e. capable of) direct the proximal bone screws toward the greatest thickness of the medial cuneiform bone (12).
Regarding claim 16, Bltiz discloses a method for a bone fusion plate (20) (¶10), comprising forming an elongate member (¶8 and figure 2) having a proximal contact surface (24) and a distal contact surface (22), adapting the proximal contact surface (24) to be attached to a medial cuneiform bone (12) (figures 5A, 5B, 6), configuring the distal contact surface (22) to be attached to a 1st metatarsal bone (10) (figures 5A, 5B, 6), and forming a medial thickness (¶25) that orients proximal bone screws (70) toward the greatest thickness of the medial cuneiform bone (12) (figures 5A, 5B, 6).
Regarding claim 17, Bltiz discloses wherein adapting includes forming one or more proximal apertures (52) (¶27) for implantation of proximal bone screws into the medial cuneiform bone (12) (¶31 and figures 5A, 5B, 6).
Regarding claim 18, Bltiz discloses wherein configuring includes forming one or more distal apertures (46) (¶26) for implantation of distal bone screws into the 1st metatarsal bone (10) (¶32 and figures 5A, 5B, 6).
Regarding claim 19, Bltiz discloses wherein configuring further includes creating a spacing (figure 2) that provides clearance for a cross screw that may be used to treat a Lisfranc injury (considered functional).
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) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blitz (US 2014/0379036) in view of Hatch et al. (US 2023/0263557), herein referred to as Hatch.
Regarding claim 14, Blitz’s bone fusion plate discloses all the features/elements as claimed but lacks a detailed description on wherein the medial thickness is greater than the lateral thickness, such that the one or more proximal apertures are disposed at a lateral angle with respect to the proximal contact surface.
However, Hatch teaches a medial thickness (855) is greater than a lateral thickness (856) (¶80 and figure 8A), such that one or more proximal apertures (824) are disposed at a lateral angle (¶82 and figure 8A) with respect to a proximal contact surface (figure 8A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Blitz’s bone fusion plate with wherein the medial thickness is greater than the lateral thickness, such that the one or more proximal apertures are disposed at a lateral angle with respect to the proximal contact surface as taught by Hatch, since such a modification would provide an alternative plate profile, wherein Blitz clearly contemplates varying plate thicknesses (¶25).
Regarding claim 15, the modified Blitz’s bone fusion plate has wherein the lateral angle (figure 8A of Hatch) is configured to (i.e. capable of) direct the proximal bone screws toward an apex of the medial cuneiform bone (12 of Blitz).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SI MING KU whose telephone number is (571)270-5450. The examiner can normally be reached Monday-Friday, 9:30am-6pm.
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/SI MING KU/Primary Examiner, Art Unit 3775
