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 . 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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (note p5, last paragraph). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claims Status
Claims 1-8, 15, and 16 are pending.
Claims 4-7 have been amended.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The MPEP states “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is ‘undue.’ These factors include, but are not limited to: 1) the breadth of the claims; 2) the nature of the invention; 3) the state of the prior art; 4) the level of one of ordinary skill; 5) the level of predictability in the art; 6) the amount of direction provided by the inventor; 7) the existence of working examples; and 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure” (MPEP 2164.01(a).
1 and 2) the breadth of the claims and the nature of the invention: The claim uses oral vancomycin to treat S saprophyticus infections.
3) the state of the prior art: Wilhelm (Mayo Clinic Proc. (1991) 66(11) p1165-1170) states that vancomycin is poorly absorbed from the intestinal tract, with only small amounts of the drug found in serum, even in patients with advanced renal failure (1st page, 2nd paragraph, continues to 2nd page, 1st paragraph).
Ehlers et al (StatPearls, (2023)) state that S. saprophyticus is a common cause of uncomplicated urinary tract infections, but also for pyelonephritis, epididymitis, prostatitis, and urethritis (1st page, 1st paragraph). Note that none of these disorders are of the intestinal tract. It is a normal part of human flora (1st page, 5th paragraph).
4) the level of one of ordinary skill: The level of skill in the art is high.
5) the level of predictability in the art: With animal models that closely match human disease, antimicrobials are considered one of the more predictable fields of biotechnology.
6 and 7) the amount of direction provided by the inventor and the existence of working examples: Applicant’s disclosure mentions oral administration of drugs multiple times, but there are no experiments and no evidence that any attempt at using oral vancomycin was attempted.
8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure: S. saprophyticus is not an infection of the intestinal tract. Yet vancomycin does not leave the intestinal tract. As the bacterium never contacts the antibiotic used by this administration route, it will take undue experimentation to use the invention as claimed.
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) 15 and 16 are rejected under 35 U.S.C. 102()(1) as being anticipated by Flamm et al (Antimicrob. Agents Chemother. (2017) 61(7) p1-9, cited by applicants).
Flamm et al discuss dilutions of geptadacin with vancomycin in broth (which contains water, a pharmaceutically acceptable excipient), anticipating claims 15 and 16.
Claim Rejections - 35 USC § 103
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) 1-7, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Payne et al (WO 2020201833, cited by applicants) in view of Matarneh et al (Clin. Case Rep. (2021) 9:e05183) with evidentiary support from the PubChem page for Vancomycin (downloaded 23 July, 2026).
Payne et al discusses gepotidacin for treatment of urinary tract infections (title), including uncomplicated infections from S. saprophyticus (p13, 2nd paragraph). The counterion can be methanesulphonate (p20, line 14-15). It can be administered orally, IV, subQ, IM, or topically, with oral administration preferred (p30, 6th paragraph).
The difference between this reference and the examined claims is that this reference does not discuss vancomycin administered with the gepotidacin.
Matarneh et al discuss a case study of a urinary tract infection caused by S. saprophyticus (abstract). This bacterium is the second most frequent causative microorganism in uncomplicated urinary tract infections (1st page, 1st colum, 1st paragraph). The patient was treated first with meropenem, but after culturing, the S. saprophyticus causing the disorder was not sensitive to that drug, so the antibiotic was switched to vancomycin. This successfully treated the infection (2nd page, 1st column, 2nd paragraph, continues to 2nd column, 1st paragraph). This reference shows that vancomycin is effective against S. saprophyticus in urinary tract infections.
It is not considered a patentable distinction to combine to compounds if they are both used for the same purpose, absent secondary considerations (MPEP 2144.06(I)). Therefore, it is obvious to use both gepotadacin and vancomycin to treat urinary tract infections, as both have been demonstrated effective for that purpose.
Both gepotidacin and vancomycin are effective against S. saprophyticus urinary tract infections, making the combination obvious. Thus, the combination of references renders obvious claims 1 and 2.
Both references mention uncomplicated UTIs, rendering obvious claim 3.
If the gepotidacin and vancomycin are administered via different routes, they are not administered together, and so must be administered sequentially, rendering obvious claim 4.
Payne et al mentions the methanesulfonate salt of gepotidacin, rendering obvious claim 5.
As evidenced by the PubChem page for vancomycin, the counterion in the FDA approved formulations is the hydrochloride (2nd page “description”). As all drugs administered to patients are approved by the FDA, this means that the formulation of Matameh et al must have been the hydrochloride, rendering obvious claim 6.
Payne et al mentions oral administration of gepotidacin, rendering obvious claim 7.
If the compounds are administered by the same route of administration, it is obvious to combine the formulations, rendering obvious claims 15 and 16.
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.
first rejection
Claims 1-4, 6, 7, 15, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 17/600,660 (US 20220184071) in view of Matarneh et al (Clin. Case Rep. (2021) 9:e05183).
Competing claim 10 describes a method of treating an uncomplicated UTI using oral gepotidacin.
The difference between the competing claims and the examined claims is that the competing claims do not describe vancomycin.
Matarneh et al discuss a case study of a urinary tract infection caused by S. saprophyticus (abstract). This bacterium is the second most frequent causative microorganism in uncomplicated urinary tract infections (1st page, 1st colum, 1st paragraph). The patient was treated first with meropenem, but after culturing, the S. saprophyticus causing the disorder was not sensitive to that drug, so the antibiotic was switched to vancomycin, which successfully treated the infection (2nd page, 1st column, 2nd paragraph, continues to 2nd column, 1st paragraph). This reference shows that vancomycin is effective against S. saprophyticus in urinary tract infections.
It is not considered a patentable distinction to combine to compounds if they are both used for the same purpose, absent secondary considerations (MPEP 2144.06(I)). Therefore, it is obvious to use both gepotadacin and vancomycin to treat urinary tract infections, as both have been demonstrated effective for that purpose.
This is a provisional nonstatutory double patenting rejection.
second rejection
Claims 1-4, 6, and 7are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of copending Application No. 19/100,214 (US 20260041639) in view of Matarneh et al (Clin. Case Rep. (2021) 9:e05183).
Competing claim 1 discusses an oral formulation of gepotidacin, while competing claim 15 specifies using the formulation to treat a bacterial infection.
The difference between the competing claims and the examined claims is that the competing claims do not describe vancomycin or UTI.
Matarneh et al discuss a case study of a urinary tract infection caused by S. saprophyticus (abstract). This bacterium is the second most frequent causative microorganism in uncomplicated urinary tract infections (1st page, 1st colum, 1st paragraph). The patient was treated first with meropenem, but after culturing, the S. saprophyticus causing the disorder was not sensitive to that drug, so the antibiotic was switched to vancomycin, which successfully treated the infection (2nd page, 1st column, 2nd paragraph, continues to 2nd column, 1st paragraph). This reference shows that vancomycin is effective against S. saprophyticus in urinary tract infections.
It is not considered a patentable distinction to combine to compounds if they are both used for the same purpose, absent secondary considerations (MPEP 2144.06(I)). Therefore, it is obvious to use both gepotadacin and vancomycin to treat infections, such as urinary tract infections, as both have been demonstrated effective for that purpose.
third rejection
Claims 1-4, 6, and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 21 of U.S. Patent No. 12,528,809 in view of Matarneh et al (Clin. Case Rep. (2021) 9:e05183).
Competing claim 1 discusses a formulation of gepotidacin, while competing claim 21 specifies using the formulation to treat a bacterial infection.
The difference between the competing claims and the examined claims is that the competing claims do not describe vancomycin or UTI.
Matarneh et al discuss a case study of a urinary tract infection caused by S. saprophyticus (abstract). This bacterium is the second most frequent causative microorganism in uncomplicated urinary tract infections (1st page, 1st colum, 1st paragraph). The patient was treated first with meropenem, but after culturing, the S. saprophyticus causing the disorder was not sensitive to that drug, so the antibiotic was switched to vancomycin, which successfully treated the infection (2nd page, 1st column, 2nd paragraph, continues to 2nd column, 1st paragraph). This reference shows that vancomycin is effective against S. saprophyticus in urinary tract infections.
It is not considered a patentable distinction to combine to compounds if they are both used for the same purpose, absent secondary considerations (MPEP 2144.06(I)). Therefore, it is obvious to use both gepotadacin and vancomycin to treat infections, such as urinary tract infections, as both have been demonstrated effective for that purpose.
Examiner’s Note
Applicants have stated in their disclosure that the combination of gepotidacin and vancomycin is synergistic for S. saprophyticus infections (p2, 4th paragraph). However, there are a few issues which are currently preventing this from overcoming the obviousness and double patenting rejections, above. First, it is applicant’s burden to show that the results are statistically significant (MPEP 716.02(b)(I)). This has not been demonstrated, and it is not immediately obvious from the data presented. Second, it is not clear what the practical significance of the finding is (MPEP 716.02(b)(I)). Synergy can vary from strain to strain (note table 1, p19 of specification), so a person of skill in the art cannot assume that a patient presenting with a S. saprophyticus infection will respond synergistically with the claimed combination. While screening for antibiotic susceptibility is common in the art (note Matarneh et al (Clin. Case Rep. (2021) 9:e05183), 2nd page, 1st column, 2nd paragraph, for example), testing drug combinations for synergy against a specific patient’s disorder is not. This means an artisan in this field with a patient suffering from a S. saprophyticus infection, following typical workup procedures, will know what antibiotics it is susceptible to, but NOT if any combination of the antibiotics is synergistic for that strain. That means that there is no reason for such an individual to adjust dosages to account for synergy, which means the fact that the combination is often synergistic for this infection does not have a practical effect on the treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
Examiner interviews are available via telephone 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, Melissa Fisher can be reached at 571-270-7430. 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.
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
Prosecution Insights