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 .
Response to Amendment
Applicant’s response filed 01/07/2026 has been entered. Claims 10-11, 20, and 22-24 are pending. Examiner has considered Applicant’s arguments regarding the rejection of claims 10-11, 20, and 22-24 under 35 U.S.C. 103 and finds them to be persuasive. The rejection is withdrawn. Examiner has considered Applicant’s arguments regarding the rejection of claims 10-11, 20, and 22-24 on the ground of nonstatutory double patenting over claim 22 of Application No. 17/997,293 (now issued as U.S. Patent No. 12528809 B2) and finds the arguments to be persuasive. The rejection is withdrawn.
New grounds of rejection are set forth herein.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/07/2026 has been entered.
Priority
Examiner acknowledges that, according to the Filing receipt received 11/18/2022, that the instant application 17/600,660 filed 10/02/2021 is a 371 of PCT/IB2020/000261 filed 04/03/2020, which claims benefit of the following U.S. provisional applications: 62/828,801 filed 04/03/2019; 62/834,112 filed 04/15/2019; 62/841,363 filed 05/01/2019; 62/841,375 filed 05/01/2019; 62/841,384 filed 05/01/2019; 62/295,601 filed 09/04/2019; 62/895,590 filed 09/04/2019; and 62/895,594 filed 09/04/2019.
However, the limitations of the instant claims are not adequately supported or enabled in the manner provided by 35 U.S.C. 112(a) or pre-AIA U.S.C. 112, first paragraph by the aforementioned U.S. provisional applications. More specifically, the limitations of the uncomplicated UTI being recurrent, the human patient being male, and the human patient being pregnant, adolescent, or pediatric are not taught or suggested in their entirety by any of the U.S. provisional applications. Moreover, the earliest teaching or suggestion that the human patient is female is in 62/841,363 filed 05/01/2019. As such, claims 10-11 have been awarded the effective filing date of 62/828,801 filed 04/03/2019, claim 22 has been awarded the effective filing date of 62/841,363 filed 05/01/2019, and claims 23-24 have been awarded the effective filing date of PCT/IB2020/000261 filed 04/03/2020.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scangarella-Oman et al. (Poster Abstracts; 2019; IDS filed 06/18/2025) in view of Orenstein et al. (AAFP; 1999; previously cited).
Scangarella-Oman et al. discloses a method of treating uncomplicated UTI in female subjects, wherein a subject was confirmed to have uncomplicated UTI caused by S. saprophyticus prior to treatment, comprising administering oral gepotidacin at 1,500 mg BID for five days (col. 2, Methods). Scangarella-Oman et al. teaches that the infection was resolved at Time of Cure (col. 2, Results).
Scangarella-Omandoes does not teach that the patient is male, or that the patient is pregnant, adolescent, or pediatric. This limitation is obvious over Orenstein et al.
Orenstein et al. teaches that Staphylococcus saprophyticus is a principal pathogen of acute uncomplicated UTI, recurrent UTI in women, UTI in men, and UTI in pregnant women (p. 3-4).
It would be prima facie obvious for one of ordinary skill in the art to administer gepotidacin for the treatment of UTI caused by Staphylococcus saprophyticus. One would have been motivated to do so, with reasonable expectation of success, because S. saprophyticus is a common pathogen that causes uncomplicated acute and recurrent UTI in females, including pregnant women and pediatric females, and men. One of ordinary skill in the art would be apprised that administering gepotidacin for the treatment of uncomplicated UTI would be beneficial to these patients and would be expected to yield similar results.
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 10-11, 20, and 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of copending Application No. 18/262,938 in view of Hovelius et al. (Reviews of Infectious Diseases; 1984); and Orenstein et al. (AAFP; 1999).
Claim 18 of the ‘938 application is directed toward a method of treating a bacterial infection in a subject comprising administering a composition comprising gepotidacin.
In looking to the specification of the ‘938 application to construe the scope of “bacterial infection”, page 17 of the specification filed 07/26/2023 discloses a method of treating a urinary tract infection caused by Escherichia coli (E. coli), Staphylococcus saprophyticus, Citrobacter koseri, or Klebsiella pneumoniae (K. pneumoniae) which overlaps with the instant claims.
Hovelius et al. teaches that Staphylococcus saprophyticus is a common cause of urinary tract infection that must be diagnosed by appropriate screening methods (Abstract; p. 328, col. 1). Hovelius et al. discloses that UTIs caused by S. saprophyticus can occur in both men and women, including pregnant women, and that S. saprophyticus has been identified in urine specimens of female patients as young as 15 years of age (p. 329, Figure 1; p. 330 col. 2 – p. 331 col. 2). Hovelius et al. teaches that a diagnosis of S. saprophyticus can be obtained by studying a patient’s urine sediment, rather than nitrite testing (as S. saprophyticus does not reduce nitrate), and that identification of S. saprophyticus infection can allow for appropriate therapy to be instituted at the first office visit, which is of benefit to the patient’s discomfort (p. 332, col. 1).
Orenstein et al. teaches that Staphylococcus saprophyticus is a principal pathogen of acute uncomplicated UTI, recurrent UTI in women, UTI in men, and UTI in pregnant women (p. 3-4). Orenstein et al. teaches that antibiotic therapy for these categories of UTI include sulfamethoxazoles and fluoroquinolones (p. 8-9).
It would be prima facie obvious for one of ordinary skill in the art to administer gepotidacin for the treatment of UTI caused by Staphylococcus saprophyticus, wherein the method further comprises determining that the UTI is caused by Staphylococcus saprophyticus. One would have been motivated to do so, with reasonable expectation of success, because S. saprophyticus is a common pathogen that causes uncomplicated acute and recurrent UTI in females, including pregnant women and pediatric females, and men. Moreover, one would have been apprised to the advantages of determining the cause of the UTI being S. saprophyticus in order to determine an appropriate method of treatment in the patient.
Response to Arguments
Regarding the outstanding nonstatutory double patenting rejection over co-pending application 18/262,938 as maintained above, Examiner has considered Applicant’s arguments and will consider withdrawing the rejection when no other rejections remain outstanding, per MPEP 804(I)(B)(1)(b)(i).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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, Jeffrey Murray can be reached at (571) 272-9023. 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.
/M.E.B./Examiner, Art Unit 1624 02/17/2026
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624