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 . Claims 22-41 are currently pending.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 22-24 and 37-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 13-14, 23-24 of U.S. Patent No. 9,554,849. Although the claims at issue are not identical, they are not patentably distinct from each other because the same base components are taught (catheter, three needles, three guiding elements, circumferential delivery of ablative fluid). ‘849 utilizes ethanol as the ablative fluid delivered to the exact same location by the same catheter, for the purpose of treating hypertension, however it does not explicitly detail improving a secondary condition. However, the exact same method is taught and based on the Applicant’s present specification if ablative fluid is provided in that same area, these other conditions will have been improved. The prior art performs the identical methods and any subsequently recognized therapeutic benefit such as improving (to no claimed degree) diabetes and obstructive sleep apnea would have also occurred naturally. If there are other steps that are taken specifically to affect this improvement beyond injecting ethanol as taught by ‘849, it would overcome the present rejection.
Claims 22-26, 37-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,022,059 in view of McGuckin Jr. et al. US Patent 7,087,040 (hereinafter McGuckin). Although the claims at issue are not identical, they are not patentably distinct from each other because the same base elements are taught (catheter, needles, guiding elements, circumferential delivery of ablative fluid, specifically ethanol, and includes sensing the perivascular space around the renal artery). But is silent on the needles and needle guiding elements being at a quantity of three (only two are detailed). McGuckin teaches at least three elements (guides 33 and needles 24 at Figure 3). Therefore, it would have been obvious to the skilled artisan before the effective filing date to duplicate another guide/needle combination as taught by McGuckin with the device of ‘059 as predictable results would have ensued (increased sensing/ablation areas).
Additionally regarding claim 37-41, ‘059 utilizes ethanol as the ablative fluid delivered to the exact same location by the same catheter, for the purpose of treating hypertension, however it does not explicitly detail improving a secondary condition. However, the exact same method is taught and based on the Applicant’s present specification if ablative fluid is provided in that same area, these other conditions will have been improved. The prior art performs the identical methods and any subsequently recognized therapeutic benefit such as improving (to no claimed degree) diabetes and obstructive sleep apnea would have also occurred naturally. If there are other steps that are taken specifically to affect this improvement beyond injecting ethanol as taught by ‘059, it would overcome the present rejection.
Claims 22-25, 29 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. US 9,179,962. Although the claims at issue are not identical, they are not patentably distinct from each other because the same claimed subject matter including the catheter, advancing three guide elements including three needles for placement and ablation in a circumferential ring around the same claimed renal artery. Beyond the interior space includes the perivascular space, and though the vessel size isn’t mentioned, it is the same vessel (renal artery, so it would have the same dimensions)
Claim 27-28 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 9,179,962 in view of Burch US Publication 2012/0071832 (hereinafter Burch). ‘962 is silent on the uniform spread at 120 degrees, and though three needles/guiding tubes are used and would reasonably be spaced apart equally, Burch specifically details this ([0032 at advanced portions 80 around catheter 12). It would have been obvious to the skilled artisan before the effective filing date to utilize the spacing as taught by Burch with the device of ‘962 as predictable results would have ensued (keeping the device centered and allowing an actual ring to form of ablation fluid as claim 1 of ‘962 requires; if offset this would not be likely possible to accomplish).
Claims 30, 32, 34, and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim16, 19, 20 of U.S. Patent No. 12,239,361. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘361 details the catheter, advancing three guide elements including three needles for the purposes of ablating sympathetic nerve fibers outside of the artery using fluid (slowly over a period of 10 or 30 seconds) for reducing pain. The ”only one” fluid of claim 34 is still considered met as claim 17 details injecting “a fluid” and does not detail additional fluids.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian M Antiskay whose telephone number is (571)270-5179. The examiner can normally be reached M-F 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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