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 .
DETAILED ACTION
Claims 1-36 are pending in the application. Claims 1, 2, 4-10, 17-26, 28 and 30-36 are rejected. Claims 3, 11-16 and 27 are objected to. Claim 29 is allowed.
Response to Amendment / Argument
Objections and rejections made in the previous Office Action that do not appear below have been overcome by Applicant's amendments to the claims. Therefore, arguments pertaining to these objections and rejections will not be addressed.
On page 10 of the response filed September 18th, 2025, Applicant addresses the Examiner’s position on priority. Applicant refers to formulas II, IIII, IX and X, XI and XII for alleged support of the term “amido” and “C1-C6 alkyl” as substituents in variable “A”. These disclosures provide support for the specific substituents on these particular rings but not for broadening the scope of the generic formula to provide for these substituents on all types of rings. Applicant could convert the dependent claims to independent form and remove the problematic substituents from the independent claims to be consistent with the priority document. The same rationale applies to Applicant’s traversal of the variable “D” on page 11 of the response. Applicant’s prior art traversals on page 12 of the response are not found persuasive for these reasons.
On pages 11 and 12 of the response filed September 18th, 2025, Applicant addresses the rejection of claims under 35 USC 112(b) but does not address the issue raised over claim 17, which is maintained below.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/965,507, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The provisional application fails to disclose that:
(1) the variable “A” can be substituted by C1-C6 alkyl or amido or that the ring formed between A and R1 can be substituted by C1-C6 alkyl or amido, as instantly claimed; and
(2) the variable “D” can be substituted by C1-C6 alkyl or amido.
Since at least one of the differences above affect the scopes of instant claims 1-28 and 30-36, the earliest effective filing date for these claims is January 22nd, 2021.
Claim Rejections - 35 USC § 112(b)
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.
Claim 17 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 17 recites the broad recitation “C1-C6 alkyl, -C(=O)- or C4-C6 cycloalkyl”, and the claim also recites “unsubstituted methyl, ethyl, propyl, butyl, cyclobutyl, or cyclopentyl” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. In this situation, the broader range recite alkyl and cycloalkyl as generic terms and examples falling therein; however, the broader range also recites “-C(=O)-“ which option is not found in the narrowed range. It is unclear why this option is recited in the broader range if there are no embodiments in which it can be present.
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, 2, 4-10, 17-26, 30 and 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okumu et al. Eur. J. Med. Chem. 2020, 199, 112324, which was available online as of April 28th, 2020. As noted above, the earliest effective filing date for the instant rejected claims is January 22nd, 2021.
The prior art teaches the following compounds on page 4:
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The compounds are embraced by instant formula I where the dashed line is a bond that is absent, R1 and R2 are H, A is bicyclic heteroaryl that is monosubstituted by C1 alkoxy or disubstituted by C1 alkoxy and halide, B is C1 alkyl and D is aryl or heteroaryl that is unsubstituted or substituted with hydroxy, C1 alkyl or halide. At least one compound is embraced by instant claims 1, 2, 4, 5 (where R4 is C1 alkoxyl and R5 is H or F), 6, 7, 8, 9, 10, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26 (regarding instant claims 23-26, compounds 22, 23 and 25 are embraced by each of these claims since they require that D” be formula IV where R6 is H or C1 alkyl and Y variables are moot), 28 and 36. Regarding instant claim 30, the prior art teaches that the compounds are topoisomerase inhibitors in the abstract.
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.
Claim(s) 1, 2, 4-10, 17-26, 28 and 30-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okumu et al. Eur. J. Med. Chem. 2020, 199, 112324, which was available online as of April 28th, 2020. As noted above, the earliest effective filing date for the instant rejected claims is January 22nd, 2021.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Okumu et al. teach the development of topoisomerase inhibitors (abstract) where “Compound 6 also displayed excellent activity against fluoroquinolone-resistant MRSA (MIC90 = 2 mg/mL) and other Gram-positive pathogens.” The prior art teaches the following compounds on page 4:
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The compounds are embraced by instant formula I where the dashed line is a bond that is absent, R1 and R2 are H, A is bicyclic heteroaryl that is monosubstituted by C1 alkoxy or disubstituted by C1 alkoxy and halide, B is C1 alkyl and D is aryl or heteroaryl that is unsubstituted or substituted with hydroxy, C1 alkyl or halide. At least one compound is embraced by instant claims 1, 2, 4, 5 (where R4 is C1 alkoxyl and R5 is H or F), 6, 7, 8, 9, 10, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26 (regarding instant claims 23-26, compounds 22, 23 and 25 are embraced by each of these claims since they require that D” be formula IV where R6 is H or C1 alkyl and Y variables are moot), 28 and 36. Regarding instant claim 30, the prior art teaches that the compounds are topoisomerase inhibitors in the abstract.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art anticipates instant claims 1, 2, 4-10, 17-26, 30 and 36 where anticipation is the epitome of obviousness. The prior art does not teach an embodiment where a prior art compound, such as compound 6, was administered a subject as required by instant claim 31.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
The prior art teaches the following on page 8:
We undertook the synthesis and evaluation of a series of NBTIs with a linker derived from isomannide. These compounds demonstrated potent antibacterial activity against Gram-positive bacterial pathogens such as MRSA and an improved in vitro safety profile as compared to other linker moieties. Compound 6 displayed excellent activity against fluoroquinolone-resistant MRSA (MIC90 = 2 mg/mL), a moderate hERG IC50 (66 mM), and generally favorable ADMET properties. […]
At least in the interest of testing the in vivo utility of the prior art compounds, a person having ordinary skill in the art would have been motivated to test application of compound 6 in the treatment of an MRSA infection as embraced by instant claims 31-33. Regarding instant claim 35, the prior art teaches on page 1 that “In patients with cystic fibrosis, Staphylococcus aureus, including methicillin-resistant S. aureus (MRSA), constitutes one of the most important bacterial pathogens”. Accordingly, a person having ordinary skill in the art would have been specifically motivated to treat MRSA infections in patients of instant claim 35. Regarding instant claim 34, the instant specification defines “treatment” as including “preventing” on page 4 (lines 23-28) such that administration to any patient would be embraced by instant claim 34.
Allowable Subject Matter
Claims 3, 11-16 and 27 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 29 is allowed.
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 MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626