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. Election/Restrictions Applicant’s election without traverse of claims 32-33 in the reply filed on 29 December 2025 is acknowledged. Claims 1-31 and 34-38 are withdrawn from consideration. 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 32-33 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 9-10 of U.S. Patent No. 11,524,140 . Although the claims at issue are not identical, they are not patentably distinct from each other because each element of the claims of the instant application is anticipated by a similarly phrased element from the prior patent. While minor differences in phrasing are present, there does not appear to be any non-obvious distinction between the current claims and those of the prior patent . Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claims 32-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 32, there is insufficient antecedent basis for the limitation of “the first target tissue site”. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claim(s) 32 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by WO 2019/165500 to Lubowski et al. (Lubowski hereinafter) . Regarding claim 32, Lubowski teaches a method (illustrated in Figs. 9a-9h) for positioning a catheter in a target tissue site to deliver a medicament to a patient after haemorrhoid surgery, the method including: providing a first catheter (100) which extends from a proximal end (102) to a distal end (101) , the first catheter having a sidewall which defines an internal lumen, the distal end of the catheter having one or more apertures for the release of the medicament to the target tissue site; making a first incision (at point A, paragraph 120) in the skin on one side of the anus; making a lateral incision (at point C, paragraph 123) in the skin of the thigh of the patient; connecting the proximal end of the first catheter to an end of a first trocar (300) ; tunnelling the first trocar from the first incision through the tissue and through the lateral incision (shown in Fig. 9a) ; pulling the first trocar from the lateral incision until a desired length of the first catheter is pulled through the lateral incision, such that the proximal end of the first catheter extends from the lateral incision and the distal end of the first catheter extends from the first incision (Fig. 9b) ; disconnecting the proximal end of the first catheter from the trocar (Fig. 9e) ; connecting the distal end of the first catheter to a stimulator trocar (400) , the stimulator trocar comprising an elongate body (400) and a nerve stimulating electrode (410) configured to stimulate nerves in the target tissue site; advancing the stimulator trocar, together with the distal end of the first catheter, through the tissue of the patient (Fig. 9e) ; actuating the nerve stimulator at a determined frequency (see paragraphs 15-16) ; adjusting the positioning of the stimulator trocar and the distal end of the first catheter until a physical contraction of the external anal sphincter is observed at a frequency that correlates with the determined frequency of the nerve stimulator; identifying the location of the nerve stimulator and the distal end of the catheter where the physical contraction of the external anal sphincter is achieved as the first target tissue site; disconnecting the stimulator trocar from the first catheter and withdrawing the stimulator trocar through the first incision leaving the distal end of the catheter implanted in the first target tissue site (Fig. 9f) ; and connecting the proximal end of the catheter to a reservoir of medicament and infusing the medicament through the internal lumen of the catheter to deliver the medicament to the first target tissue site (paragraph 15) . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT PHILIP E STIMPERT whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-1890 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday, 8a-4p . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Chelsea Stinson can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-1744 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /PHILIP E STIMPERT/ Primary Examiner, Art Unit 3783 18 March 2026