DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Receipt is acknowledged of amendment filed 01/08/2026. Claims 1-13 and 15-24 are pending and an action on the merits is as follows.
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 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,129,664. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed towards almost identical systems including an elongated catheter with first and second flow channels, flow media source, heating mechanism, pressure source and controller for thin layer ablation to cause an alteration of hormonal function.
Allowable Subject Matter
A medical system for ablation of a targeted site of a patient, the medical system comprising: a catheter having a handle coupled to an elongate member with a working end, the catheter having a flow channel extending from the handle to the working end; an energy source in the handle configured to deliver a flow media, a cooling media, and an inflation fluid to the working end via the flow channel; a proximal expandable structure expandable by the inflation fluid, wherein a region distal to the proximal expandable structure comprises the targeted site; a distal expandable structure expandable by the inflation fluid, wherein the targeted site is between the proximal expandable structure and the distal expandable structure; one or more outlets located distal to the proximal expandable structure and proximal to the distal expandable structure, wherein the flow media and the cooling media are provided to the targeted site via the one or more outlets; and a controller operatively connected to the energy source for controlling the energy source. The prior art fails to disclose the system and method as claimed. The closest prior art is regarded as DeFord (US 5,304,214). The examiner also notes that the priority date of the present application is 05/31/2008. As such, permissible prior art must occur before that date.
Prior to the priority date, the prior art of record and available fails to disclose a system with a catheter having a flow channel extending therethrough, and energy source in the handle configured to deliver three different fluid medias to the working end, and a distal and proximal expandable structure with one or more outlets located in between with a controller to control an energy source. While DeFord does disclose distal and proximal inflatable structures, it fails to disclose outlets occurring between the two structures and that the outlets provide for inflation, cooling and a flow media as claimed by the present application.
The cited references alone or in combination fail disclose the cited arrangement and one of ordinary skill would not create the claimed system in the claimed arrangement without the motivation provided by the applicant.
Claims 13 and 15-24 are allowed.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 01/08/2026, with respect to claims 13 and 15-24 have been fully considered and are persuasive. The 102 and 103 rejections of claims 13 and 15-24 has been withdrawn.
As indicated above, a double patenting rejection has been issued and is maintained in the present response.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/A.L.Z/ Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/ Primary Examiner, Art Unit 3794
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