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 25-44 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 Pub. No. 2018/0116727 to Caldwell et al., U.S. Patent Pub. No. 2008/0089566 to Node-Langlois et al., U.S. Patent Pub. No. 2016/0354161 to Deitz, and U.S. Patent Pub. No. 2007/0276501 to Betz et al. disclose a computer-implemented method, instructions for, and system for designing a patient-specific implant. The method comprising displaying a model of at least a portion of a patient’s spinal anatomy in a virtual space, updating the model to display a corrected spinal anatomy in the virtual space that includes one or more changes to the patient’s spinal anatomy, determining one or more predicted post-operative spinal metrics associated with the corrected spinal anatomy, the one or more predicted post-operative spinal metrics including lumbar lordosis, and designing a patient-specific longitudinal element based at least in part on the corrected spinal anatomy.
The prior art fails to teach or disclose, however, wherein the one or more changes include changes to a spatial relationship between at least two vertebrae, and wherein the multi-planar patient-specific longitudinal element includes one or more curved segments sized and shaped based on the corrected spinal anatomy.
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 25-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,245,952. 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 a computer-implemented method of designing a patient-specific implant. The method comprises displaying an image or model of at least a portion of a patient's spinal anatomy, updating the image or model to display a corrected spinal anatomy that includes one or more changes to the patient's spinal anatomy, wherein the one or more changes include changes to a spatial relationship between at least two vertebrae, determining one or more predicted post-operative spinal metrics associated with the corrected spinal anatomy, the one or more predicted post-operative spinal metrics including one or more of pelvic tilt, sagittal alignment, or lumbar lordosis, and designing a patient-specific longitudinal element based at least in part on the corrected spinal anatomy, wherein the multi-planar patient-specific longitudinal element includes one or more curved segments sized and shaped for stabilizing the patient's spine in the corrected spinal anatomy.
Both the present application and granted patent disclose a system for providing patient-specific care. The system comprises a surgical planning software tool configured to display an image or model of at least a portion of a patient's spinal anatomy, update the image or model to display a corrected spinal anatomy that includes one or more changes to the patient's spinal anatomy, wherein the one or more changes include changes to a spatial relationship between at least two vertebrae, determine one or more predicted post-operative spinal metrics associated with the corrected spinal anatomy, the one or more predicted post-operative spinal metrics including one or more of pelvic tilt, sagittal alignment, or lumbar lordosis, design a multi-planar patient-specific longitudinal element based at least in part on the corrected spinal anatomy, wherein the patient-specific longitudinal element includes one or more curved segments sized and shaped for stabilizing the patient's spine in the corrected spinal anatomy.
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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