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 Objections
Claim 1 is objected to because of the following informalities:
Claims 1, lines 11 and 12, “the plate and” should be changed to “the plate section” for reasons of consistently and clarity.
Appropriate correction is required.
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 1 – 14 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.
In claim 1, lines 8-9, the recitation “at least two bone fixation fasteners”, “a first fastener” and “a second faster” is indefinite because it is unclear what applicant is intended to claim, e.g. at least two fasteners, or at least four fasteners (i.e. at least two fastener + a first fastener + a second fastener). Based on that the embodiments shown in the drawings show at least two fasteners, the recitation “at least two bone fixation fasteners; a first fastener..., and a second fastener ...” will be interpreted as -- at least a first fastener and a second fastener; the first fastener …, and the second fastener …”. Applicant is advised to correct the claim limitation as interpreted.
In claim 14, line 1, “the bone fixation fasteners” is indefinite because it is unclear to what applicant is referring to. e.g. “at least two bone fixation fasteners” or “a first fastener and a second fastener” or the combination of “at least two bone fixation fasteners”, “first fastener” and “second fastener” or “at least two bone fixation fasteners” and “second fastener”. For examination purposes, the claim limitation “the bone fixation fasteners” will be interpreted as -- the at least first and second fasteners -- and should be corrected as such.
Claim Rejections - 35 USC § 102
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 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, 3, 7, 8, 12 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tyber et al. (US 2015/0032220 A1).
Regarding claim 1 (as understood), 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 bone fixation fasteners (Fig. 21, ref. 2100, 2114, 2112, 2118); a first fastener disposed with the first opening (Fig. 21, ref. 2114), and a 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).
Regarding claim 3, Tyber discloses the implant system of claim 1 wherein the selected angular orientation is about 15 degrees (paragraph [0076]).
Regarding claim 7, Tyber 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 (paragraph [0068] discloses a plurality of peaks or teeth ref. 112 on each of the surfaces, Figs. 1, 4).
Regarding claim 8, Tyber discloses the implant system of claim 1 wherein the spacer section has one or more graft holes (Fig. 1, ref. 118, paragraph [0069]).
Regarding claim 12, Tyber 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 (paragraph [0067] discloses a titanium coating).
Regarding claim 14 (as understood), Tyber discloses the implant system of claim 1 wherein the bone fixation fasteners are selected from the group consisting of bone screws, helical nails, distally expanding nails, and distally expanding screws (Fig. 21 and paragraph [0085] disclose bone screws).
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) 2 and 4 - 6 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 2, Tyber discloses the implant system of claim 1, except for 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 teaches an osteotomy system (Title) comprising a plate (Fig. 1) having a first a second washer (paragraph [0039], ref. 50), the washers being disposed within a first and second opening (Figs. 1 – 2, ref. 20) for the purpose of allowing screws to be oriented at an angle other than perpendicular to the bone plate while allowing a finished position with the screw head flush with an outer surface of the plate (paragraph [0012]). 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 to include 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, as taught by Brunsvold, for the purpose of allowing the bone fixation 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.
Regarding claim 4, Tyber discloses the implant system of claim 1, except wherein the first opening and the second opening are threaded bore holes.
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]). 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]), 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 5, Tyber in view of Brunsvold discloses the implant system of claim 4 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 6, Tyber in view of Brunsvold discloses the implant system of claim 4 wherein the threaded bore holes of the first and second openings direct the first and second fasteners at different angular orientations (because the fasteners are independently inserted, they are fully capable of having different angular orientations).
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 Zdeblick et al. (US 6,613,091 B1).
Regarding claim 9, Tyber 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 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 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 discloses the implant system of claim 8 wherein the graft hole contains bone graft (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 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 Blain (US 2006/0235403 A1).
Regarding claim 11, Tyber 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 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 Serhan et al. (US 2008/0154375 A1).
Regarding claim 13, Tyber 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 such that the body comprises carbon fiber, as taught by Serhan, for the purpose biocompatibility (paragraph [0060]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 which lists the prior art used in the rejections above and other analogous fusion implants.
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/TESSA M MATTHEWS/Examiner, Art Unit 3773