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 .
Status of Claims
This office action is responsive to the amendment filed on 03/01/2026. As directed by the amendment: claims 1, 4, 10 and 11 have been amended, no claims have been cancelled and no new claims have been added. Thus, claims 1-18 are presently pending in this application, and currently examined in the Office Action.
Terminal Disclaimer
The terminal disclaimer filed on 03/01/2026 is NOT accepted because the person who signed the terminal disclaimer is not the applicant, patentee or an attorney or agent of record; see response dated 03/23/2026 for details.
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 and 4-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,738,184, hereinafter ‘184. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose a method of expanding a prostatic urethra comprising a collapsed implant including a distal retractor including two distal protrusions/peripheral ridges connected by a connecting member/central ridge and a proximal retractor, inserting said collapsed implant in a collapsed state into the prostatic urethra; orienting said implant in the prostatic urethra with said distal retractor cranial to said proximal retractor; orienting/aligning said implant with said connecting member/central ridge toward an anterior side of the prostatic urethra; positioning said distal protrusions/peripheral ridges within the prostatic urethra proximal to a bladder neck thereof; expanding/opening said distal protrusions/peripheral ridges within a cranial portion of the prostatic urethra on opposite posterior-lateral sides of said bladder neck; expanding lateral walls of a cranial portion of the prostatic urethra adjacent to the bladder neck; resting said distal protrusions/peripheral ridges on a cranial side of said bladder neck to prevent migration of said implant into a urinary bladder; and opening said proximal retractor to support and expand lateral walls of a caudal portion of said prostatic urethra caudal to said cranial portion (claim 1 of current application & claim 1 of '184); the method further comprising supporting a wall of an intermediate portion of said prostatic urethra between said cranial retractor/portion and said caudal retractor/portion on an anterior side thereof by said central ridge and on a posterior side thereof by said two peripheral ridges wherein in said intermediate portion said two peripheral ridges have a closed form with at least a portion of a space between the two peripheral ridges and the central ridge being empty such that lateral walls of the urethra between the central ridge and the two peripheral ridges are unsupported (claim 4 of current application & claim 2 of '184); the method further comprising the implant being open between said two distal protrusions/peripheral ridges on a posterior side of the prostatic urethra, and further leaving said posterior side of the prostatic urethra unsupported during said opening of said proximal retractor and said opening of said distal retractor (claim 5 of current application & claim 4 of '184); the method further comprising the distal retractor being arc shaped and further supporting lateral walls of said cranial portion with said distal retractor (claim 6 of current application & claim 5 of '184); the method further comprising the distal retractor being arc shaped and further supporting lateral walls of said caudal portion with said proximal retractor (claim 7 of current application & claim 6 of '184); the method further comprising supporting a wall of an intermediate portion of said prostatic urethra between said cranial portion and said caudal portion is on an anterior side thereof by said central ridge and on a posterior side thereof by said two peripheral ridges wherein in said intermediate portion, the walls of the urethra between the central ridge and the peripheral ridges are unsupported (claim 8 of current application & claim 7 of '184); the method further comprising, wherein the implant is open on a posterior side of the prostatic urethra between said distal and proximal retractors/two peripheral ridges, leaving said posterior side of the prostatic urethra unsupported during said opening of said proximal retractor and said opening of said distal retractor (claim 9 of current application & claim 8 of '184); the method further comprising aligning said connecting member/central ridge with an anterior interlobar groove of said prostatic urethra (claim 10 of current application & claim 9 of '184); the method further comprising aligning comprising transferring a torque applied to a manipulator connected to the implant (claim 11 of current application & claim 10 of '184); the method further comprising connecting a manipulator to said proximal retractor (claim 12 of current application & claim 11 of '184); the method further comprising causing the implant to laterally compress and retreat within a deployment lumen when an alignment or a position of the implant is incorrect (claim 13 of current application & claim 12 of '184); the method further comprising the causing includes pulling said manipulator proximally towards said deployment lumen (claim 14 of current application & claim 13 of '184); the method further comprising detaching said manipulator from said proximal retractor (claim 15 of current application & claim 14 of '184); the method further comprising said connecting is to two caudolateral corners of the proximal retractor (claim 16 of current application & claim 15 of '184); the method further comprising opening said distal retractor and opening said proximal retractor are sequential (claim 17 of current application & claim 16 of '184); and the method further comprising supporting lateral walls of said cranial portion between said central ridge and said two peripheral ridges by said distal retractor (claim 18 of current application & claim 3 of '184).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 04/07/2026