DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the amendments received after a Non-Final Rejection on 03 February 2026. Claims 28-47 are currently pending.
Non-Statutory 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 28-30, 32 and 34-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 10, 12-13, 15-17 and 19 of U.S. Patent No. 12,090,065. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are merely broader than the patent claims.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. U.S. Patent No. 12,090,065 in view of Scribner et al. (U.S. Patent 7,771,431).
Claims 1, 3, 5, 10, 12-13, 15-17 and 19 of U.S. Patent No. 12,090,065 disclose the claimed method except for wherein the liquid comprising the sclerosing agent is administered using the first delivery device and bone graft material is administered using a second delivery device.
Scribner et al. teach varying the number and type of instruments in a group of a kit (see column 4, lines 42-44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the method of claims 1, 3, 5, 10, 12-13, 15-17 and 19 of U.S. Patent No. 12,090,065 with wherein the liquid comprising the sclerosing agent is administered using the first delivery device and bone graft material is administered using a second delivery device in view of Scribner et al. in order to provide an additional, well-known and obvious means for administering a desired agent. Furthermore, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art (St. Regis Paper Co. v. Bemis Co., 193 USPQ 8).
Claim 33 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. U.S. Patent No. 12,090,065 in view of Pasetti et al. (“Cirse 2017”).
Claims 1, 3, 5, 10, 12-13, 15-17 and 19 of U.S. Patent No. 12,090,065 disclose the claimed method except for wherein the image-guidance is used to place the venting device and a delivery device into the treatment volume.
Pasetti et al. teach puncturing a bone volume, administering an agent (e.g. a sclerosing agent), and administering a bone graft material (e.g. a ceramic bone void filler) under fluoroscopic control (see P-90 on page S192).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the method of claims 1, 3, 5, 10, 12-13, 15-17 and 19 of U.S. Patent No. 12,090,065 with wherein the image-guidance is used to place the venting device and a delivery device into the treatment volume in view of Pasetti et al. in order to provide a well-known, obvious means for treating the bone volume in real-time.
Claims 40 and 42-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-21 and 23-24 of U.S. Patent No. 12,090,065. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Claim 41 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of U.S. Patent No. U.S. Patent No. 12,090,065 in view of Scribner et al. (U.S. Patent 7,771,431).
Claims 19-21 and 23-24 of U.S. Patent No. 12,090,065 disclose the claimed invention except for wherein the kit further comprises a second delivery device, wherein the first delivery device is capable of administering the bone graft material to the treatment volume and the second delivery device is capable of administering the sclerosing agent to the treatment volume.
Scribner et al. teach varying the number and type of instruments in a group of a kit (see column 4, lines 42-44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of claims 19-21 and 23-24 of U.S. Patent No. 12,090,065 with wherein the liquid comprising the sclerosing agent is administered using the first delivery device and bone graft material is administered using a second delivery device in view of Scribner et al. in order to provide an additional, well-known and obvious means for administering a desired agent. Furthermore, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art (St. Regis Paper Co. v. Bemis Co., 193 USPQ 8).
Response to Arguments
The examiner recognizes the applicant’s willingness to submit a terminal disclaimer with respect to U.S. Patent No. 12,090,065. Since a terminal disclaimer was not received with the applicant’s arguments/remarks, a Final Rejection is being mailed.
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 LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775