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 .
Election/Restrictions
Applicant’s election of Species A, drawn to claims 1-4, 6-9, 12-18, and 20 in the reply filed on August 3, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Allowable Subject Matter
Claims 1-4, 6-9, 12-18, and 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 Pub. No. 2019/0298417 to Barrett et al., U.S. Patent No. 8,162,979 to Sachs et al., U.S. Patent Pub. No. 2003/0225442 to Saadat, and U.S. Patent No. 3,960,151 to Kuhn disclose a system for stimulating growth. The system comprises a housing that comprises biocompatible material and a geometry suitable for surgical implantation. The system includes a retractor including a reel disposed in the housing, and a drive disposed in the enclosed space and operably coupled to the reel. The drive comprises an energy storage system, and a linkage operably coupled to the reel and configured to rotate the reel and retract the line using energy from the energy storage system. A second end of the system is configured for surgical attachment to an end of a nerve of the vertebrate. A tube structure is adapted for receiving therein a distal end of a severed nerve by having the distal end of the severed nerve sutured to an inner or outer surface of the tube structure,
The prior art fails to teach or disclose, however, the structural arrangement allowing for a pharmaceutical delivery modality disposed inside, outside, or partially within the housing to be adapted to deliver a pharmaceutical agent or other treatment modality to the nerve.
The prior art fails to teach or disclose, however, the structural arrangement including a tensioning device adapted for connection to the tube structure to apply a controllable tension to the tube structure thereby providing stretching stimulation to the severed nerve.
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 1-4, 6-9, and 12-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,220,128. 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 system for stimulating nerve growth that is operable by a retractor to apply longitudinal force to a nerve, regulating the applied longitudinal force to the nerve, the retractor being at least partially disposed in a housing that includes a geometry suitable for surgical implantation. The system includes a pharmaceutical delivery module including a pump, and a controller operably coupled to the pump to administer a pharmaceutical agent to the nerve during application of longitudinal force to the nerve.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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