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 § 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) 1-2, 4, 6-7, 12, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yuan et al (WO2022052487A1).
Yuan recites a system for performing posterior spinal arthrodesis at a facet joint. Specifically in regards to claim 1 and 14, Wang recites an implant device (1/2, Fig. 1) being comprised of an element (2) having a proximal side (side with 1) with a proximal side opening (4), a distal side opposite said proximal side (side with 1) and being closed, a first face (face furthest from 7, Fig. 2), a second face (face closest to 7, Fig. 2) opposite said first face, and at least one opening (6) through said first to said second faces being configured to receive a bone graft in a cavity previously made at a location of the facet joint to be immobilized, said first face and said second face having reliefs (5) (The recitation of the cavity being made at a location of the facet joint is being interpreted as a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The implant 2 recited in Yuan is similar in structure as applicant’s implant and is capable of being used as a facet implant.) (Fig. 1-2; and Para. [0019],[0021]-[0028]). Yuan also recites a bone graft within the at least one opening (6) (Para. [0021]). A retaining means being comprised of a transfacet screw (3) wherein the screw comprises a threaded distal part (part furthers from fixing plate 1) being positioned outward from said first face (face furthest from 7 as shown in Fig. 2) and being configured to engage bone material downstream of said implant device (1/2) on said first face, a proximal part (head, Fig. 1) being positioned outward from said second face (Fig. 2) and being configured to engage bone material upstream of said material upstream of said implant device (1/2) on said second face, and a section (section passing through 71 Fig. 1-2) between said threaded distal part and said proximal part and extended to through the at least one opening (6) from said first to said second face so as to pass through said bone graft (Fig. 1-2; and Para. [0021]).
In regards to claim 2, Yuan recites wherein said element (2) is flat with a constant thickness (Fig. 1 and 3).
In regards to claim 4, Yuan recites wherein said implant (1/2) device is flexible (Para, [0012]).
In regards to claim 6, Yuan recites the at least one openings (6) has an annular shape (Fig. 2).
In regards to claim 7, Yuan recites wherein said element (2) is comprises of a transverse portion on said proximal side and two arms connected to said transverse portion so as to form said implant device (2) as U-shaped (Fig. 2).
In regards to claim 12, Yuan recites wherein said proximal part (head) is comprised of a head configured to bear against the bone material (Fig.1).
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) 1-3 and 6-14 is/are rejected under 35 U.S.C. 103 as being unpatentable Wang et al (CN201219922Y) in view of Tyber et al (US Patent Pub. 20150032220A1).
Wang recites a system for performing posterior spinal arthrodesis at a facet joint. Specifically in regards to claim 1, Wang recites an implant device (1, Fig. 2) being comprised of an element (11) having a proximal side (side with 12) with a proximal side opening (opening on 12), a distal side opposite said proximal side (side with 12) and being closed, a first face (face furthest from 21), a second face (face closest to 21) opposite said first face, and at least one opening (13) through said first to said second faces being configured to receive a bone graft in a cavity previously made at a location of the facet joint to be immobilized (The recitation of the cavity being made at a location of the facet joint is being interpreted as a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The implant 1 recited in wang is similar in structure as applicant’s implant and is capable of being used as a facet implant.) (Fig. 2-4; and Para. [0025]-[0027]). A retaining means being comprised of a transfacet screw (2) wherein the screw comprises a threaded distal part (part opposite head in Fig. 5) being positioned outward from said first face (face furthest from 21 as shown in Fig. 2and 7) and being configured to engage bone material downstream of said implant device (1) on said first face, a proximal part (conical head, Fig. 5) being positioned outward from said second face (Fig. 7) and being configured to engage bone material upstream of said material upstream of said implant device (1) on said second face, and a section (unthreaded screw section Fig. 5) between said threaded distal part and said proximal part and extended to through the at least one opening (13) from said first to said second face so as to pass through said bone graft (Fig. 5 and 7; and Para. [0026],[0028]). However, the reference is silent as the implant having reliefs on the first and second faces.
Tyber recites a spinal implant system. Specifically in regards to claim 1, recites an implant (100) having first and second faces (116,117) and proximal and distal sides (113,114) wherein the proximal side (113) has a side opening (120/119) and the first and second faces have reliefs (112) (Fig. 1; and Para. [0068]-[0070]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the first and second faces of the implant (1) of Wang to have reliefs as taught in Tyber in order to have a means to grip the superior and inferior bone portions (Para. [0071]).
In regards to claim 2, Wang recites wherein said element (11) is flat with a constant thickness (Fig. 2 and 8).
In regards to claim 3, Wang recites wherein said implant device (11) has a curved shape (curved end) (Fig. 2-3).
In regards to claim 6, Wang recites the at least one openings (13) has an annular shape (Fig. 3).
In regards to claim 7, Wang recites wherein said element (11) is comprises of a transverse portion on said proximal side and two arms connected to said transverse portion so as to form said implant device (11) as U-shaped (Fig. 3).
In regards to claim 8, Wang recites wherein said proximal part (conical part) is threaded and wherein thread pitch of said proximal part (conical part) is smaller than a thread pitch of said threaded distal part (Fig. 5).
In regards to claim 9, Wang recites wherein said section (non-threaded part) between the distal part and said proximal part (conical part) is smooth (Fig. 5).
In regards to claim 10, Wang recites wherein said proximal part (conical part) has a diameter larger than a diameter of the distal part (Fig. 5).
In regards to claim 11, Wang in view of Tyber recite a system as recited above. Wang recites a screw having threads at the proximal and distal parts (Fig. 5). However, the reference is silent as to the proximal and distal parts having tapping notches. Tyber further recites a screw (2620) wherein threads of the distal part (2640) are comprised of a tapping notch (3820), and wherein threads of said proximal part (2630) are comprised of a respective tapping notch (3620) (Fig. 36-38; and Para. [0093]-[0095]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the proximal and distal parts of the screw (2) of Wang to have tapping notches as taught in Tyber in order to have a means to remove material as needed if the screw needs to be removed or to cut into the bone as the bone is inserted (Para. [0093]-[0094]).
In regards to claim 12, Wang recites wherein said proximal part (conical part) is comprised of a head configured to bear against the bone material (Fig.11).
In regards to claim 13, Wang recites wherein said section is smooth below head so as to pass bone material between said second side of said implant device (11) and said head (Fig. 2 and 7).
In regards to claim 14, Wang recites a system for performing posterior spinal arthrodesis at a facet joint. Specifically, Wang recites an implant device (1, Fig. 2) being comprised of an element (11) having a proximal side (side with 12) with a proximal side opening (opening on 12), a distal side opposite said proximal side (side with 12) and being closed, a first face (face furthest from 21), a second face (face closest to 21) opposite said first face, and at least one opening (13) through said first to said second faces being configured to receive in a cavity previously made at a location of the facet joint to be immobilized (The recitation of the cavity being made at a location of the facet joint is being interpreted as a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The implant 1 recited in wang is similar in structure as applicant’s implant and is capable of being used as a facet implant.) (Fig. 2-4; and Para. [0025]-[0027]). A bone graft within the at least one opening (Para. [0028]). A retaining means being comprised of a transfacet screw (2) wherein the screw comprises a threaded distal part (part opposite head in Fig. 5) being positioned outward from said first face (face furthest from 21 as shown in Fig. 2and 7) and being configured to engage bone material downstream of said implant device (1) on said first face, a proximal part (conical head, Fig. 5) being positioned outward from said second face (Fig. 7) and being configured to engage bone material upstream of said material upstream of said implant device (1) on said second face, and a section (untreaded screw section Fig. 5) between said threaded distal part and said proximal part and extended to through the at least one opening (13) from said first to said second face so as to pass through said bone graft (Fig. 5 and 7; and Para. [0026],[0028]). However, the reference is silent as the implant having reliefs on the first and second faces.
Tyber recites a spinal implant system. Specifically in regards to claim 14, recites an implant (100) having first and second faces (116,117) and proximal and distal sides (113,114) wherein the proximal side (113) has a side opening (120/119) and the first and second faces have reliefs (112) (Fig. 1; and Para. [0068]-[0070]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the first and second faces of the implant (1) of Wang to have reliefs as taught in Tyber in order to have a means to grip the superior and inferior bone portions (Para. [0071]).
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments filed on 2/3/25 have been fully considered but are moot since they do not pertain to the new combination of references.
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 MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775