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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/10/26 has been entered.
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 an opening (6) through said first to said second faces being configured to receive a bone graft within said opening (6) 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]). 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, said threaded distal part being positioned relative to said first face (face furthers from 7, Fig. 2) according to the bone material downstream of said implant device, 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, said proximal part being positioned relative to said second face according to the bone material upstream of said implant device and said bone graft within said opening (6), and a section (section passing through 71 Fig. 1-2) between said threaded distal part and said proximal part and extended through both said opening (6) from said first to said second face so as to pass through said bone graft within said opening (Yuan recites wherein the opening 6 is for fitting a graft therein.) (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 said opening (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 an opening (13) through said first to said second faces being configured to receive a bone graft within said opening (13) 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, said threaded distal part being positioned relative to said first face according to the bone material downstream of said implant device, 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 said proximal part being positioned relative to said second face according to the bone material upstream of said implant device and said bone graft within said opening (13), and a section (unthreaded screw section Fig. 5) between said threaded distal part and said proximal part and extended to through said opening (13) from said first to said second face so as to pass through said bone graft within said opening (13) (Wang recites wherein the cavity 13 is filled with autologous bone particles.) (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 said opening (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 said 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 an 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 received within said opening (Wang recites wherein the cavity 13 is filled with autologous bone particles.) (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, said threaded distal part being positioned relative to said first face according to the bone material downstream of said implant device, 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 said proximal part being positioned relative to said second face according to the bone material upstream of said implant device and said bone graft within said opening (13), and a section (untreaded screw section Fig. 5) between said threaded distal part and said proximal part and extended through both said opening (13) from said first to said second face and through said bone graft within said opening (13) (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 allowed.
The closest art of record Yuan and Wang while reciting implant device for use on a facet joint and being comprising of an element having a central cavity holding bone graft material and having a transfacet screw therethrough do not recite wherein the reliefs comprise a plurality of notches arranged perpendicularly to either the respective first or second faces, and wherein the notches comprise a tooth profile having two sides wherein one faces the proximal side and is perpendicular to the respective first or second face. Therefore, the claims of the instant application have not been rejected using prior art because none of the references or reasonable combinations thereof could be found which disclose or suggest all of the features of the claims, and there is no reasonable motivation to modify the art of record to have these features. Furthermore, attempting to modify the references to have all the cited limitations would destroy the proposed inventions.
Response to Arguments
Applicant’s arguments filed on 6/10/26 have been fully considered but not persuasive.
Applicant argues against the Yuan reference reciting that the element does not have a single opening through which both the screw and graft extend (Remarks Pg. 6-8). Specifically, Applicant points to the images showing the screw passing through opening 71 located within the main cavity 6 and how cavity 6 holds the graft material thereby not allowing for the screw to interact with the graft material. Applicant also recites that the threaded hole 7 on the guide plate of the device determines the relationship of the screw with the faces of the cage and that the plate is incapable of functioning as a posterior facet. However, this is merely a conclusory statement. Applicant provides no specific arguments that are directed to the invention claimed as compared to the relied upon references. Instead, Applicant recites a general allegation that the claims define a patentable invention relying on merely conclusory statements without specifically pointing out how the language of the claims patentably distinguishes them from the references. For this reason, the continued rejection of the claims is proper. As to the argument regarding the location of the screw, the screws positioning shown in Applicant’s specification at Fig. 3-4 wherein the head is on one side of the cage and the threaded end is on the other side is similar to what is shown in Yuan’s reference at Fig. 1 wherein the head and hook plate are capable of being situated in one bone and the threaded end is in a bone opposite the cage.
Applicant argues that the combination of Wang and Tyber do not render the claims obvious since they do not describe that the threaded distal part of the screw is positioned relative to the first face of the implant according to the bone material downstream of the device while the proximal part of the screw is positioned relative to the second face accosting the material upstream of the device and the graft within the cavity (Remarks Pg. 9-13). Applicant recites that the screw cannot be positioned relative to the cage due to the hook plate of the device and since the hook plate cannot fit within a cavity between two different bone material of a facet joint the device cannot be used as a facet joint plate (Remarks Pg. 10). However, the use of the plate in the facet joint is interpreted as an intended use recitation. 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. In the instant case, the device of Wang is fully capable of being positioned in a facet joint with the hook plate being situated outside the joint. As to the argument regarding the location of the screw, the screws positioning shown in Applicant’s specification at Fig. 3-4 wherein the head is on one side of the cage and the threaded end is on the other side is similar to what is shown in Wang’s reference at Fig. 11 wherein the head and hook plate are in one bone and the threaded end is in a bone opposite the cage. As for the Tyber reference it is not being bodily incorporated into the Wang reference but is merely to demonstrate that using reliefs on a cage device was known in the art at the time the invention was file. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
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.
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
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