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 .
Response to Arguments
Applicant's arguments filed 07/29/2026 have been fully considered but they are not persuasive.
Applicant argues that the angular range disclosed by Tyber does not anticipate a range of about 10 to 20 degrees. More specifically, Tyber discloses a range of about 0 to 90 degrees which is 800 percent larger than the claimed range. The Office respectfully disagrees. Tyber discloses a range that fully encompasses the narrower claimed range; therefore, Tyber discloses every value within the claimed range. Because no criticality is given for a range of 10 – 20 degrees and because Tyber discloses an implant system which is analogous in form and function, the rejection based upon anticipation is maintained.
Applicant argues that Tyber in view of Brunsvold does not teach or suggest a system wherein the threaded bore holes of the first and second openings direct the first and second fasteners at different angular orientations. The Office respectfully disagrees. Brunsvold in paragraph [0012] discloses “to be oriented at an angle other than perpendicular to the bone plate”. Therefore, Brunsvold teaches a threaded opening configured to engage a threaded screw head such that the screw may be oriented at a variety of angles and thus “different angular orientations”.
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 – 3, 5, 7, 8, 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tyber et al. (US 2015/0032220 A1) in view of Brunsvold (US 2005/0209599 A1).
Regarding claim 1, Tyber discloses an implant system (Abstract) fully capable for atlanto-occipital fusion (paragraph [0008] discloses a bone fusion system, thus being fully capable of being used for atlanto-occipital fusion) comprising:
a. a body (Fig. 19) having a spacer section (refs. 800, 100, Figs. 8, 19) and a plate section (ref. 1500);
i. the spacer section comprising an occipital condyle engaging surface (Fig. 8, ref. 116) and a C1 lateral mass engaging surface (Fig. 8, ref. 117), the occipital condyle engaging surface being disposed relative to the C1 lateral mass engaging surface at a selected angular orientation (Fig. 8, ref. 812);
ii. the plate section defining at least a first opening (Fig. 15, ref. 1520) and a second opening (ref. 1520); and
b. at least two a first fastener and a second fastener (Fig. 21, ref. 2100, 2114, 2112, 2118); the first fastener disposed with the first opening (Fig. 21, ref. 2114), and the second fastener disposed with the second opening (Fig. 21, ref. 2112);
wherein the first fastener being engageable with the plate and capable of fixing with the occipital condyle and the second fastener being engageable with the plate and capable of fixing with the C1 lateral mass and further (this is considered a functional limitation in which the fasteners, shown as screws, are fully capable of fixing with the C1 lateral mass and the occipital condyle since they are configured to be engaged with bone, see Figs. 43 - 45), wherein the selected angular orientation of the occipital condyle engaging surface relative to the C1 lateral mass engaging surface is from about 10 degrees to about 20 degrees (paragraph [0076] discloses a range from about 0 to 90 degrees which encompasses the claimed range of about 10 to about 20 degrees).
Tyber is silent that the first opening and the second opening are threaded bore holes and the threaded bore holes of the first and second openings direct the first and second fasteners at different angular orientations.
Brunsvold teaches an osteotomy plate with locking washers (Title) comprising a plate (Fig. 1) having first and second openings (Fig. 1, ref. 20, 50) wherein the openings are threaded bore holes (Fig. 2, paragraph [0011]) configured to receive a threaded fastener (paragraph [0011]) and the threaded bore holes of the first and second openings direct the first and second fasteners at different angular orientations (paragraph [0012] discloses that the fasteners may be oriented at any angle other than perpendicular, thus at different angular orientations). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Tyber such that the first and second openings are threaded bore holes configured to receive a threaded fastener (paragraph [0011]) and the threaded bore holes of the first and second openings direct the first and second fasteners at different angular orientations, as taught by Brunsvold, for the purpose of allowing the fasteners to be oriented at an angle other than perpendicular to the plate section while allowing a finished position with the fastener’s head flush with an outer surface of the plate section (paragraph [0012]).
Regarding claim 2, Tyber in view of Brunsvold discloses the implant system of claim 1, further comprising at least a first washer and a second washer, the first washer being disposed with the first opening and the second washer being disposed with the second opening (Brunsvold, ref. 50).
Regarding claim 3, Tyber in view of Brunsvold discloses the implant system of claim 1 wherein the selected angular orientation is about 15 degrees (Tyber, paragraph [0076]).
Regarding claim 5, Tyber in view of Brunsvold discloses the implant system of claim 1 wherein the threaded bore holes of the first and second openings direct the first and second fasteners at the same angular orientation (the fasteners are independently inserted through the threaded hole, which includes a washer to lock in a desired angle, thus being fully capable of being at the same angular orientation).
Regarding claim 7, Tyber in view of Brunsvold discloses the implant system of claim 1 wherein the occipital condyle engaging surface and the C1 lateral mass engaging surface comprise projections selected from the group consisting of teeth, ridges, spikes and combinations thereof (Tyber, paragraph [0068] discloses a plurality of peaks or teeth ref. 112 on each of the surfaces, Figs. 1, 4).
Regarding claim 8, Tyber in view of Brunsvold discloses the implant system of claim 1 wherein the spacer section has one or more graft holes (Tyber, Fig. 1, ref. 118, paragraph [0069]).
Regarding claim 12, Tyber in view of Brunsvold discloses the implant system of claim 1 wherein the body comprises a material selected from the group consisting of carbon fiber, polylactic acid, stainless steel alloys, commercially pure titanium, titanium alloys, ceramics, thermoplastics, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers,polyolefin rubbers, hydrogels, semi-rigid and rigid materials (Tyber, paragraph [0067] discloses a titanium coating).
Regarding claim 14, Tyber in view of Brunsvold discloses the implant system of claim 1 wherein the at least first fastener and second fastener are selected from the group consisting of bone screws, helical nails, distally expanding nails, and distally expanding screws (Tyber, Fig. 21 and paragraph [0085] disclose bone screws).
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tyber et al. (US 2015/0032220 A1) in view of Brunsvold (US 2005/0209599 A1) and in view of Zdeblick et al. (US 6,613,091 B1).
Regarding claim 9, Tyber in view of Brunsvold discloses the implant system of claim 7 wherein the spacer section has one graft hole (ref. 118, paragraph [0069], Fig. 1), but is silent that the hole is from about 3 to about 5 mm wide and about 8 to about 12 mm long.
Zdeblick teaches a fusion implant (Abstract) comprising a graft hole (ref. 24) having dimensions from about 6 mm wide to about 7 mm long (Col. 8, lines 5 – 10). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Tyber in view of Brunsvold such that the graft hole is from about 3 to about 5 mm wide and about 8 to about 12 mm long (note that 6mm is within a +20% of 5 mm and 7 mm is within about -20% of 8mm which is within the claimed tolerances due to the definition of “about” as disclosed in paragraph [0040] of the application), as taught by Zdeblick, for the purpose of being large enough to accept graft material without compromising the structural integrity of the device (Col. 8, lines 15 – 20).
In addition, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the graft hole of Tyber in view of Brunsvold such that the graft hole is from about 3 to about 5 mm wide and about 8 to about 12 mm long, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 10, Tyber in view of Brunsvold discloses the implant system of claim 8 wherein the graft hole contains bone graft (Tyber, paragraph [0069]), but is silent that the bone graft is one of autograft, allograft or a combination thereof.
Zdeblick teaches a fusion implant (Abstract) comprising a graft hole (ref. 24) comprising autograft (Col. 5, lines 60 – 65). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Tyber in view of Brunsvold such that the bone graft is autograft, as taught by Zdeblick, for the purpose of promoting a solid fusion (Col. 5, lines 63-65).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tyber et al. (US 2015/0032220 A1) in view of Brunsvold (US 2005/0209599 A1) and in view of Blain (US 2006/0235403 A1).
Regarding claim 11, Tyber in view of Brunsvold discloses the implant system of claim 1, except for comprising two or more bodies having the same configuration.
Blain teaches a fusion system (Abstract) comprising a body (ref. 268, Fig. 20) wherein the system comprises two or more bodies having the same configuration (paragraphs [0136, 142], Fig. 20). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the plate shape of Tyber in view of Brunsvold such that the system comprises two or more bodies having the same configuration which are complimentary, to allow for the placement of additional implants without interference between them (paragraph [0136]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tyber et al. (US 2015/0032220 A1) in view of Brunsvold (US 2005/0209599 A1) and in view of Serhan et al. (US 2008/0154375 A1).
Regarding claim 13, Tyber in view of Brunsvold discloses the implant system of claim 1, except wherein the body comprises carbon fiber.
Serhan teaches a fusion implant (Abstract) comprising carbon fiber (paragraph [0060]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the body of Tyber in view of Brunsvold such that the body comprises carbon fiber, as taught by Serhan, for the purpose biocompatibility (paragraph [0060]).
Conclusion
THIS ACTION IS MADE FINAL. 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 TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TESSA M MATTHEWS/Examiner, Art Unit 3773
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