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 .
Allowable Subject Matter
Claims 1-20 are allowable over the prior art.
The following is a statement of reasons for the indication of allowable subject matter:
Most pertinent prior art, including U.S. Patent No. 7,044,972 to Mathys, Jr. et al., U.S. Patent No. 5,702,449 to McKay, and U.S. Patent Pub. No. 2011/0046737 to Teisen disclose an implant sized and adapted to be placed between adjacent bones, and a method of reducing peak stresses between an implant and adjacent bones comprising providing the implant, and implanting the resorbable component between the first and second adjacent bones so that top and bottom surfaces of the resorbable component contact the respective bone surfaces of the first and second bones over a contact surface area sufficient to reduce peak stresses between the framework and the first and second adjacent bones. The implant comprises a non-resorbable, structural framework having top and bottom bone-contacting surfaces and a plurality of struts defining geometric openings between the top and bottom surfaces, the struts providing structural support for the framework, wherein the framework includes a plurality of support columns extending between proximal and distal ends of the framework, the plurality of support columns being spaced apart from each other to define vertical openings in the framework. The implant can include a resorbable material component within and/or around the framework, wherein the resorbable material component includes top and bottom bone-contacting surfaces configured to contact the adjacent bones over a contact surface area sufficient to reduce peak stresses between the framework and the adjacent bones.
The prior art fails to teach or disclose, however, the structural relationship including but not limited to wherein at least a portion of the framework is interposed with the resorbable material component.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,537,666. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and granted patent disclose an implant sized and adapted for insertion between adjacent bones. The implant comprises a non-resorbable, structural framework having top and bottom bone-contacting surfaces and a plurality of struts defining geometric openings between the top and bottom surfaces, the struts providing structural support for the framework, wherein the framework includes a plurality of support columns extending between proximal and distal ends of the framework, the plurality of support columns being spaced apart from each other to define vertical openings in the framework. The implant includes a resorbable material component within and/or around the framework, at least a portion of the framework being interposed between the resorbable material component, the resorbable material component having top and bottom bone-contacting surfaces arranged to contact adjacent bones over a contact surface area sufficient to reduce peak stresses between the framework and the vertebral bodies to reduce or eliminate subsidence of the framework into the adjacent bones.
Both the present application and granted patent disclose a method of reducing stresses between an implant and bone. The method comprises providing an implant having a non-resorbable structural framework and a resorbable structural component positioned within and/or around the framework, at least a portion of the framework being interposed between the resorbable structural component, implanting the framework between first and second adjacent nones so that top and bottom surfaces of the framework contact vertebral endplates of the first and second adjacent bones, and implanting the resorbable component between the first and second adjacent bones so that top and bottom surfaces of the resorbable component contact the bone surface, wherein the top and bottom surfaces of the resorbable component contact the bone surface over a contact surface area sufficient to reduce peak stresses between the framework and the adjacent bones by an amount effective to eliminate or reduce subsidence of the framework into the adjacent bones.
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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