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.
Election/Restrictions
Applicant’s election of species without traverse in the reply filed on 06/15/2026 is acknowledged.
Applicants elected compliant species
One species of compound of formula I:
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where R1 is Br; R2 is H; Z is CH; Y is C-CH3 and X is N.
One species of therapeutic agent: clofazimine.
Examiners found prior art for applicants elected species. Therefore Markush search is not extended further as Markush search practices.
Elected species read on claims 3-11 and 14-19.
Current Status of 18/294,472
This Office Action is in response to the amended claims of 06/15/2026.
Claims 3-11 and 14-19 are previously presented.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 02/01/2024. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Priority
Effected filing date is 08/17/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claim 11 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Claim 11 contains at least one occurrence of parentheticals see the circled parentheticals bellow:
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.
Claims are not allowed to have limitations within parentheticals since the readers does not know whether the limitation within the parentheticals are merely exemplary or a required limitation of the claims. Only abbreviations are allowed in parentheticals. Thus, parentheticals of claim 11 renders metes and bounds of claim 11 undefined hence rendering claim 11 indefinite.
Claim 11 contains at least one occurrence the phrase “e.g.” The examiner does not know whether the limitation following “e.g.” are merely exemplary or a required limitation of the claims. Thus, the “e.g.” of claim 11 renders metes and bounds of claim 11 undefined hence rendering claim 11 indefinite.
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 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) 3-11 and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over;
Gruber et.al. (Angew.Chem. Int. Ed. 2020, 59,13295-13304)
In view of
Dick et.al (Dick et.al (Antimicrob Agents Chemother. 2020 April, v 64(4)pe 2404-19)
In further view of
Heysell et.al (Pulmonary Pharmacology & Therapeutics 70 (20th July 2021) 102058)
1. Determining the scope and contents of prior art.
Gruber teaches electrochemical gradient drives the energy converter F1FO ATP (F-ATP) synthase and is required for viability of growing and non-growing mycobacteria (page 13295, column 2). A potent ATP synthesis inhibitor of mycobacterial F-ATP synthase is a drug target to treat mycobacteria infections (page 13296, column 1, paragraph 1).
Gruber et.al. further teaches compound of formula I
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where R1 is Br; R2 is H; Z is CH; Y is C-CH3 and X is N of instant claims 3-11 (as inhibitor the growth of various mycobacterium (page 13298, Figure 3) and is an inhibitor of ATP synthesis (page 13298) (partially reaching claims 3-11). Thus, this ATP synthesis inhibitor compound, above, is useful to treat mycobacterium infections.
Dick et.al discloses F-ATP inhibitor TBAJ-876 (analog of bedequiline) is active against Mycobacterium abscessus and can be used against lung disease caused by Mycobacterium abscessus (abstract). Dick et.al. teaches F-ATP inhibitor TBAJ-876 can be used with other antibiotics for treating lung disease caused by Mycobacterium abscessus (abstract), partially teaching claims 14-16 and 18-19.
Heysell et.al teaches treatment of pulmonary Mycobacterium abscessus infection with clofazimine (applicant elected species of other therapeutic agent) and other antibiotics (page 5).
2. Ascertaining the differences between the prior art and the claims at issue.
Gruber teaches compound of formula I
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as an inhibitor of F-ATP synthase and inhibits growth of various mycobacterium. However, Gruber does not teaches the method treatment of bacterial infections caused by Mycobacterium absecessus with compound of formula I. Furthermore Gruber et.al does not use of compound
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in combination with additional therapeutics for treating bacterial infection caused by Mycobacterium absecessus.
Although Dick et.al. teaches compound TBAJ-876, an inhibitor of F-ATP synthase, which is active against Mycobacterium absecessus and can be used with additional therapeutic. Dick et.al does not teach a method of treating bacterial infection caused by Mycobacterium absecessus with compound
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in combination with additional therapeutics.
Although Heysell et.al. teaches treatment of pulmonary Mycobacterium absecessus infection with clofazimine. Heysell et.al does not teach a method of treating bacterial infection caused by Mycobacterium absecessus with compound
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in combination with clofazimine.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill in an artisan who has sufficient training in treating bacterial infection.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in art would be motivated to treat infections caused by Mycobacterium absecessus with compound
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, F-ATP synthase inhibitor (Gruber page 13298, Figure 3) because electrochemical gradient drives the energy converter F1FO ATP (F-ATP) synthase and is required for viability of growing and non-growing mycobacteria (Gruber page 13296, column 1, paragraph 1). Furthermore, Dick et.al teaches F-ATP inhibitor, TBAJ-876 (analog of bedequiline) is active against Mycobacterium abscessus and can be used against lung disease caused by Mycobacterium abscessus (Dick et.al. abstract) therefore it would be obvious for a person skilled in the art to use
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also a F-ATP synthase inhibitor (Gruber page 13298, Figure 3) to develop a method of treating infections caused by Mycobacterium abscessus because F-ATP synthase inhibitor is expected to treat infections caused by Mycobacterium abscessus thus teaching claims 3-11. Therefore, it would be prima facie obvious to combine teaching of Gruber et.al with the teaching of Dick et.al to develop a method of treating infections caused by Mycobacterium abscessus with compound
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applicant’s elected species.
A person skilled in art would be motivated to combine
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(a F-ATP synthases inhibitor) (page 13298, Figure 3) which is expected to treat infections caused by Mycobacterium abscessus, (see above analysis) with clofazimine because clofazimine has been shown to be effective in treating infections caused by Mycobacterium abscessus (Heysell, page 5). A person skilled in art is expected to combine
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with clofazimine to develop a pharmaceutical composition to treat infections caused by Mycobacterium abscessus, since combination of
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and clofazimine is expected to be more effective in treating infections caused by Mycobacterium abscessus than individually, thus teaching claims 18-19.
Furthermore, applicants would be expected to use the pharmaceutical composition above to develop a method of treating infections caused by Mycobacterium abscessus, since combination of
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and clofazimine is expected to be more effective in treating infections caused by Mycobacterium abscessus than individually, teaching claims 14-17.
Conclusion
No claims are allowed as written.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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