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 has submitted a terminal disclaimer. The double patenting rejection has been overcome.
Applicant's arguments filed November 11, 2025 have been fully considered but they are not persuasive. Applicant argues that:
Although Schlafli discloses a knurled feature, Schlafli does not disclose "diamond knurls arranged about a central axis of the locking hole." As disclosed the in the present application, the diamond knurls allows for both fixed and variable angle locking screws with conical variability up to 10 degrees. The diamond knurls is neither taught nor suggested by Schlafli nor does Schlafli disclose this feature provides the benefit of having a both fixed and variable angle locking screws with conical variability.
Examiner maintains that Schlafli teaches the claimed feature, as described in [0022] including diamond knurls arranged about a central axis of a hole (7). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the diamond knurls allows for both fixed and variable angle locking screws with conical variability up to 10 degrees) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Examiner suggests, however, amending to include the argued feature, e.g. “wherein the diamond knurls allows for both fixed and variable angle locking screws with conical variability up to 10 degrees,” as Examiner agrees that Schlafli does not teach this limitation, and its inclusion in independent claims 1 and 11 would overcome the combination of Dahners and Schlafli.
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.
Claims 11-13 and 15-20 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 11 recites the limitation "the locking hole" in 8. 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-3, 6, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2008/0234677 to Dahners et al. in view of U.S. Patent Pub. No. 2006/0195104 to Schlafli et al.
As to Claim 1, Dahners discloses a bone fixation system (Fig. 3, [0008]). The system comprises a bone plate (60, [0040]) having an upper surface (62) and a lower surface (64) configured to be in contact with a bone (B, Fig. 3, [0043-0044]), the bone plate having a locking hole (60, [0058]) with a textured portion (85, [0058]) arranged about a central axis of the locking hole (Figs. 2A-2B, [0058-0059]). The system includes a locking fastener (10, [0037]), having a head portion (40) and a shaft portion (20), configured to configured to engage the textured portion (via 102) and to be inserted into the bone [0058].
As to Claim 2, Dahners discloses a bone fixation system, the bone plate (60) having a locking hole (A, Fig. 4) that includes the textured portion (85) and wherein the locking hole is generally conical in shape (Fig. 4, [0050]) such that it is wider (near 85, Fig. 4) near the upper surface of the plate and narrower (towards 95, Fig. 3) toward the lower surface of the plate [0050].
As to Claim 8, Dahners discloses a bone fixation system wherein the head portion (40) is conical (Fig. 4, [0050]).
As to Claim 9, Dahners discloses a bone fixation system wherein the head portion (40) is spherical (Fig. 1, [0039]).
As to Claims 1-3, 6, 8, and 9, Dahners discloses the claimed invention except for wherein the textured portion comprises diamond knurls.
Schlafli discloses a stabilization system (Fig. 3) wherein the textured portion comprises a knurled surface (interior bore 7, knurling described in [0022]). The textured portion comprises diamond knurls (interior bore 7, knurling described in [0022]). The textured portion includes a pattern of crossed lines cut into the plate (interior bore 7, knurling described in [0022]) in order to enhance grip of the fastener within the opening [0022].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stabilization system of Dahners with the knurling modification of Schlafli in order to enhance grip of the fastener within the opening.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2008/0234677 to Dahners et al. in view of U.S. Patent Pub. No. 2006/0195104 to Schlafli et al. in view of U.S. Patent Pub. No. 2017/0202585 to Leak et al.
As to Claim 5, Dahners and Schlafli disclose the claimed invention except for wherein the shaft comprises dual lead threads for engagement with bone.
Leak discloses a stabilization system (Fig. 1) wherein the shaft comprises dual lead threads for engagement with bone (Fig. 25, [0099]) in order to enhance engagement with the target bone [0099].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stabilization system of Dahners and Schlafli with the dual lead thread modification of Leak in order to enhance engagement with the target bone.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2008/0234677 to Dahners et al. in view of U.S. Patent Pub. No. 2006/0195104 to Schlafli et al. in view of U.S. Patent Pub. No. 2015/0216571 to Impellizzeri.
As to Claim 7, Dahners and Schlafli disclose the claimed invention except for wherein the head portion is made of material that is harder than the textured portion.
Impellizzeri discloses a stabilization system (1) wherein the head portion (of screw, [0090]) is made of material that is harder than the textured portion [0090] in order to provide a mechanism for engaging the fasteners with the plate [0090].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stabilization system of Dahners and Schlafli with the material modification of Impellizzeri in order to provide a mechanism for engaging the fasteners with the plate.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2008/0234677 to Dahners et al. in view of U.S. Patent Pub. No. 2006/0195104 to Schlafli et al. in view of U.S. Patent No. 6,139,550 to Michelson.
As to Claim 10, Dahners and Schlafli disclose the claimed invention except for a blocking screw configured to cover a portion of the fastener in a locked position to prevent the fastener from backing out of the plate.
Michelson discloses a stabilization system (Col. 13, Lines 12-40) including a blocking screw (25) configured to cover a portion of the fastener in a locked position to prevent the fastener from backing out of the plate (Col. 13, Lines 32-40) in order to lock the fasteners into place (Col. 13, Lines 32-40).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stabilization system of Dahners and Schlafli with the blocking screw modification of Michelson in order to lock the fasteners into place.
Claims 11-13, 16, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2008/0234677 to Dahners et al. in view of U.S. Patent No. 8,100,955 to Blain et al. in view of U.S. Patent Pub. No. 2006/0195104 to Schlafli et al.
As to Claim 11, Dahners discloses a bone fixation system (Fig. 3, [0008]). The system comprises a bone plate (60, [0040]) having an upper surface (62) and a lower surface (64) configured to be in contact with a bone (B, Fig. 3, [0043-0044]), the bone plate having a textured portion (85, [0058]) arranged about a central axis of a locking hole (Figs. 2A-2B, [0058-0059]). The system includes a locking fastener (10, [0037]), having a head portion (40) and a shaft portion (20), configured to configured to engage the textured portion (via 102) and to be inserted into the bone [0058].
As to Claim 12, Dahners discloses a bone fixation system, the bone plate (60) having a locking hole (A, Fig. 4) that includes the textured portion (85) and wherein the locking hole is generally conical in shape (Fig. 4, [0050]) such that it is wider (near 85, Fig. 4) near the upper surface of the plate and narrower (towards 95, Fig. 3) toward the lower surface of the plate [0050].
As to Claim 18, Dahners discloses a bone fixation system wherein the head portion (40) is conical (Fig. 4, [0050]).
As to Claim 19, Dahners discloses a bone fixation system wherein the head portion (40) is spherical (Fig. 1, [0039]).
As to Claims 11-13, 16, 18, and 19, Dahners discloses the claimed invention except for a spacer configured to be inserted between two adjacent bodies, and wherein the textured portion comprises a knurled surface, wherein the textured portion comprises diamond knurls.
Blain discloses a stabilization system (Fig. 10A) including a spacer (114) configured to be inserted between two adjacent bodies (Fig. 10A) in order to allow for stabilization of the system when used between adjacent vertebral bodies (Col. 4, Lines 31-38).
Schlafli discloses a stabilization system (Fig. 3) wherein the textured portion comprises a knurled surface (interior bore 7, knurling described in [0022]). The textured portion comprises diamond knurls (interior bore 7, knurling described in [0022]). The textured portion includes a pattern of crossed lines cut into the plate (interior bore 7, knurling described in [0022]) in order to enhance grip of the fastener within the opening [0022].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stabilization system of Dahners with the spacer modification of Blain in order to allow for stabilization of the system when used between adjacent vertebral bodies, and with the knurling modification of Schlafli in order to enhance grip of the fastener within the opening.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2008/0234677 to Dahners et al. in view of U.S. Patent No. 8,100,955 to Blain et al. in view of U.S. Patent Pub. No. 2006/0195104 to Schlafli et al. in view of U.S. Patent Pub. No. 2017/0202585 to Leak et al.
As to Claim 15, Dahners, Blain, and Schlafli disclose the claimed invention except for wherein the shaft comprises dual lead threads for engagement with bone.
Leak discloses a stabilization system (Fig. 1) wherein the shaft comprises dual lead threads for engagement with bone (Fig. 25, [0099]) in order to enhance engagement with the target bone [0099].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stabilization system of Dahners, Blain, and Schlafli with the dual lead thread modification of Leak in order to enhance engagement with the target bone.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2008/0234677 to Dahners et al. in view of U.S. Patent No. 8,100,955 to Blain et al. in view of U.S. Patent Pub. No. 2006/0195104 to Schlafli et al. in view of U.S. Patent Pub. No. 2015/0216571 to Impellizzeri.
As to Claim 17, Dahners, Blain, and Schlafli disclose the claimed invention except for wherein the head portion is made of material that is harder than the textured portion.
Impellizzeri discloses a stabilization system (1) wherein the head portion (of screw, [0090]) is made of material that is harder than the textured portion [0090] in order to provide a mechanism for engaging the fasteners with the plate [0090].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stabilization system of Dahners, Blain, and Schlafli with the material modification of Impellizzeri in order to provide a mechanism for engaging the fasteners with the plate.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2008/0234677 to Dahners et al. in view of U.S. Patent No. 8,100,955 to Blain et al. in view of U.S. Patent Pub. No. 2006/0195104 to Schlafli et al. in view of U.S. Patent No. 6,139,550 to Michelson.
As to Claim 20, Dahners, Blain, and Schlafli disclose the claimed invention except for a blocking screw configured to cover a portion of the fastener in a locked position to prevent the fastener from backing out of the plate.
Michelson discloses a stabilization system (Col. 13, Lines 12-40) including a blocking screw (25) configured to cover a portion of the fastener in a locked position to prevent the fastener from backing out of the plate (Col. 13, Lines 32-40) in order to lock the fasteners into place (Col. 13, Lines 32-40).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stabilization system of Dahners, Blain, and Schlafli with the blocking screw modification of Michelson in order to lock the fasteners into place.
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