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/Restriction
Applicant’s election without traverse of Lefamulin (a species of compound 1) and Treponema pallidum (a species of bacteria; the disease mediated by this is syphilis) in the reply filed on 07/30/2026 is acknowledged.
Claims 1-4, 8-12, 15, 18, 21, 23 read on the elected species.
Claims 5-6, 13, 14, 19, 20, 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/30/2026.
Note, Examiner asked for a singular fully defined compound in the election of species requirement of 07/02/2026. Claims 5 and 6 do not read on the elected species (Lefamulin).
Current Status of 18/837,088
This Office Action is responsive to the amended claims of 4/1/2026.
Claims 1-4, 8-12, 15, 18, 21, 23 are examined on the merits.
Priority
This Office Action is a national stage entry of PCT/EP2023/052949, which claims priority to US provisional application 63/308,163. This application also claims foreign priority to EP22166177.0.
The instant claims find support from the US provisional. Therefore, the effective filing date is 2/9/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/01/2026 and 10/09/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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 pages 2 and 3.
Appropriate correction is required.
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 applicant regards as his invention.
Claims 21 and 23 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 claims 21 and 23, the phrase "optionally…capsule" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Examiner is unsure if the claim requires the broader limitation of “formulation for oral administration” or the narrower limitation of tablet or capsule.
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) 1-4, 8-12, 15, 18, 21, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MANG (WO2008113089, as cited in the IDS) and as evidenced by STAMM (L V Stamm, “Syphilis: antibiotic treatment and resistance”, Epidemiol Infect., October 31, 2014).
MANG anticipates the elected species (first compound of ref claim 7). This anticipates the elected compound of claims 1-4.
MANG anticipates that the compounds of the present invention are antibacterial (page 9).
MANG anticipates using any of its compounds in a method of treatment of diseases mediated by microbes which comprises administering to a subject in need (ref claim 10). Examiner understands microbes as bacteria/bacterial infection of instant claim 1.
STAMM is relied upon for the beneficial teaching that syphilis is mediated by Treponema pallidum and syphilis treatment is antibiotics (i.e. antibacterial compounds) (abstract). STAMM also is relied upon for the beneficial teaching that Treponema pallidum is the agent of venereal syphilis (introduction) of claim 18.
MANG as evidenced by STAMM anticipates treating a bacterial infection (which includes syphilis/Treponema pallidum is a bacterial infection) with the elected species from MANG. This anticipates Treponema pallidum (and its associated disease syphilis) of claims 8-12.
MANG anticipates administering to a human subject (page 11). This anticipates claim 15.
MANG anticipates a daily dosage in the range of 500 mg to 3 g (page 11). MANG anticipates a tablet or capsule (page 11). This anticipates claim 21 and 23.
In the alternative, to the extent that MANG does not expressly disclose a method of treatment of a bacterial infection, wherein the bacterial infection is mediated by spirochetes, the instant claims are nevertheless obvious over MANG. See the obviousness rejection below.
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.
Claim(s) 1-4, 8-12, 15, 18, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over MANG (WO2008113089) and in view of STAMM (L V Stamm, “Syphilis: antibiotic treatment and resistance”, Epidemiol Infect., October 31, 2014).
MANG teaches the elected species (first compound of ref claim 7; also referred to as Lefamulin). This teaches the elected compound of claims 1-4.
MANG teaches that the compounds of the present invention are antibacterial (page 9).
MANG teaches using any of its compounds in a method of treatment of diseases mediated by microbes which comprises administering to a subject in need (ref claim 10). Examiner understands microbes as bacteria/bacterial infection of instant claim 1.
STAMM teaches that syphilis is mediated by Treponema pallidum and syphilis treatment is antibiotics (i.e. antibacterial compounds) (abstract). STAMM also teaches that Treponema pallidum is the agent of venereal syphilis (introduction) of claim 18.
MANG teaches administering to a human subject (page 11). This teaches claim 15.
MANG teaches a daily dosage in the range of 500 mg to 3 g (page 11). MANG teaches a tablet or capsule (page 11). This teaches claim 21 and 23.
MANG as evidenced by STAMM anticipates (which includes syphilis/Treponema pallidum is a bacterial infection) with the elected species from MANG. This anticipates Treponema pallidum (and its associated disease syphilis) of claims 8-12.
An artisan would find it obvious to use MANG’s method (treating a bacterial infection) to treat syphilis/Treponema pallidum. STAMM teaches that Treponema pallidum mediates or causes syphilis (including venereal syphilis) and that syphilis is a bacterial infection (abstract and introduction). The artisan would expect that Lefamulin (which is known to have antibacterial properties) to be effective in treating a bacterial infection of Treponema pallidum (i.e. syphilis). STAMM also supports this (syphilis treatment is antibiotics (i.e. antibacterial compounds) (abstract).
This teaches claims 1-4, 8-12, 15, 18, 21, and 23.
Conclusion
No claims are allowed as currently written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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