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
Election of Species and Status of the Claims
Applicant’s election without traverse of IX-520D,
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as the single specific compound in the response filed on July 16th 2026 is acknowledged. Claims 1-12, 24-26, and 36-39 are pending. Claims 2-3 and 6-8 are withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable. Claims 1, 4-5, 9-12, 24-26, and 36-39 are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on June 18th 2025 and April 16th 2025 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
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.
Claims 1, 9, 10, 11, 12, and their dependent claims 4-5, 24-26, and 36-39 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.
Claim 1 and its dependent claims 4-5, 10-12, 24-26, and 36-39 are indefinite for the phrase “β is a bond, or two bonds, or a -linker…” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the claim. Specifically, it is unclear what is intended by the phrase “two bonds.” There is no indication in the specification whether this phrase is indicative of a double bond, an atom with two bonds attaching it, or something else entirely.
Claim 1 and its dependent claims 4-5, 10-12, 24-26, and 36-39 are indefinite for the phrase, “γ is a moiety that binds to the bridge-helix N-terminus target of a bacterial RNA polymerase,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the structural moieties encompassed by the phrase. The phrase is functional-descriptive in nature and does not refer to any particular chemical moiety, but only particular activity of a moiety. While certain moieties fitting this description are found in the specification (specification, paragraphs [0122] – [0160]), at no point is the full structural scope of the phrase defined or even suggested.
Claim 9 is indefinite for the structural moiety,
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as found in multiple structures present in the claim, including applicant’s elected structure,
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The moiety is not defined anywhere in the specification, but is only used in multiple structures in place of a covalent bond. Additionally, the common use of the moiety in the art is as a dividing marker between separate chemical fragments. For example, see applicant’s claim 3:
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and claim 5:
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However, in claim 9, where the moiety is used, applicant appears to define complete chemical structures. Therefore, it is unclear whether the moiety is intended to describe a bond of variable stereochemistry, a bond of variable strength (i.e. with the option to be a single, double, or triple bond), an attachment point for a fragment, or something else entirely.
Claim 10 and its dependent claims 11 and 12 are indefinite for the phrase “wherein the compound is prepared from precursors α-β’ and ‘β-γ, where β’ and ‘β are moieties that can react to form β, because one of ordinary skill in the art could not reasonably discern the scope of moieties that comprise β’ and ‘β. Several possible precursor moieties are defined in the specification (specification, paragraphs [0210] – [0219]), but no guidance is provided as to how to determine the full scope of moieties that can react to form the bond/linker moiety β.
Claim 11 and its dependent claim 12 recite the limitation "precursors X-α’ and α’-Y" in reference to claim 10. There is insufficient antecedent basis for this limitation in the claim. The two precursors, as described, are not defined at any point in either in claim 10, in any previous claim, or int the specification. One of ordinary skill in the art would thereby be unable to determine which chemical structures are encompassed by the terms X-α’ or α’-Y.
Claim 12 is indefinite for the phrase, “wherein the bacterial polymerase serves as a template for reaction of X-α’ and ‘α-Y,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the claim. Specifically, it is never defined, either in the claims or the specification, what it means for an enzyme to “serve as a reaction template.” The specification merely repeats identical language (specification, paragraph [0208]), but provides no further guidance as to how such a reaction would be defined.
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.
Claims 1, 11, and 12, as well as their dependent claims 4-5, 10, 24-26, and 36-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 defines γ as “any moiety that binds the bridge-helix N-terminus,” a broad functionally-descriptive genus. The specification, however, describes only two structural classes that support this moiety. Specifically, the specification describes ‘CBR hydroxamines/pyrazoles,’ and ‘Nα-aroyl-N-aryl-phenylalaninamides (specification, paragraphs [0122] – [0160]). The two defined structural classes do not constitute a representative set of all binders, nor define a set of necessary structural features that correlate with binding across the functional-descriptive genus. Applicant’s written description is therefore inadequate to support the γ moiety as written. Applicant will be considered only to be in possession of the γ moiety wherein γ is a CBR hydroxamines/pyrazole or an Nα-aroyl-N-aryl-phenylalaninamide.
Claim 1 defines β as “a bond or any -linker comprising at least one atom and two bonds.” As currently written, there is no limit on which atoms/moieties may constitute said linker, but only that it must contain either “a bond” or “at least one atom and at least two bonds.” The specification does not support the indeterminately large genus of β as written. The specification only describes the linkers as “a covalent bond,” “two covalent bonds,” “a coordinate-covalent bond,” or “a chain of 0 to about 12 consecutively bonded atoms.” As described in the above 112(b) rejection for claim 1, a linker of “two covalent bonds” is indefinite. Additionally, neither any linker comprising either a coordinate-covalent bond or even a single atom is found in any structure defined by applicant. EVERY complete chemical structure defined by applicant includes a covalent bond as the β moiety. Applicant’s written description is therefore inadequate to support the β moiety as written. Applicant will be considered only to be in possession of the β moiety wherein γ is a covalent bond.
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.
Claims 1, 4-5, 9-12, 24-26, and 36-39 are rejected under 35 U.S.C. 103 as being unpatentable over Ebright (WO 2019/226915 A1 published on November 28th 2019) in view of Heep (Heep et al., 1999. Rifampin and Rifabutin Resistance Mechanism in Helicobacter pylori. Antimicrob Agents Chemother 43).
Claims 1, 4-5, and 9 are directed towards a compound of formula (I):
α-β-γ,
wherein
α is a benzoxazino-rifamycin or a spiro-rifamycin
β is a bond or a linker
γ is a moiety that binds to the bridge-helix N-terminus target of a bacterial polymerase
Applicant’s elected species of
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is one such compound, comprising a moiety that binds to the bridge-helix N-terminus target of a bacterial RNA polymerase:
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connected by a covalent bond to the spiro-rifamycin moiety, rifabutin:
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Ebright teaches the compound,
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(Ebright, claim 13).
Ebright’s compound similarly comprises the identical moiety that binds to the bridge-helix N-terminus target of a bacterial RNA polymerase, connected by a covalent bond to a rifamycin moiety. Ebright’s compound differs from applicant’s compound in that the rifamycin moiety is rifampin:
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One of ordinary skill in the art would be motivated to replace this rifampin moiety with a spiro-rifamycin moiety, such as rifabutin, because such spiro-rifamycins are known in the art to have generally greater antibacterial activity than non-spiro rifamycin compounds, and are more commonly used than rifamycins when addressing the growing problem of antibiotic-resistant bacteria (Heep, pg. 1497). Thereby, the replacement of Ebright’s rifampin moiety with a rifabutin moiety is prima facie obvious and claims 1, 4-5, and 9 are prima facie obvious.
Claim 10 is directed towards a method of making a compound as described in claim 1 wherein the compound is prepared from precursors α-β’ and ‘β-γ, where β’ and ‘β are moieties that can react to form β.
Note that applicant’s generic compound (top) and Ebright’s generic compound (bottom) are analogously defined as shown:
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Ebright teaches a method of making Ebright’s compound, wherein the compound is prepared from precursors X-α' and 'α-Y, where α' and 'α are moieties that can react to form α (Ebright, claim 22). As this is analogous to applicant’s process, claim 10 is prima facie obvious.
Claim 11 is directed to the method of claim 10, wherein precursors X-α’ and ‘α-Y are allowed to react in the presence of a bacterial RNA polymerase. Ebright teaches an analogous process (Ebright, claim 20), and claim 11 is prim facie obvious.
Claim 12 is directed to the method of claim 11, wherein the bacterial RNA polymerase serves as a template for reaction of X-α’ and ‘α-Y. Ebright teaches an analogous process (Ebright, claim 21) and claim 12 is prima facie obvious.
Claim 24 is directed towards a method of inhibiting one of the growth and viability of a bacterium via contacting the bacterium with the compound of claim 1. Ebright teaches the inhibition of growth and viability of a bacterium via contacting the bacterium with Ebright’s compound (Ebright, claim 44), and claim 24 is prima facie obvious.
Claim 25 is directed towards a method of preventing a bacterial infection comprising administering to a mammal the compound of claim 1. Ebright teaches a method of preventing a bacterial infection comprising administering to a mammal Ebright’s compound (Ebright, claim 45), and claim 25 is prima facie obvious.
Claim 26 is directed towards a method of treating a bacterial infection comprising administering to a mammal the compound of claim 1. Ebright teaches a method of treating a bacterial infection comprising administering to a mammal Ebright’s compound (Ebright, claim 46), and claim 26 is prima facie obvious.
Claim 36 is directed to a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable vehicle. Ebright teaches a pharmaceutical composition comprising Ebright’s compound and a pharmaceutically acceptable vehicle (Ebright, claim 56), and claim 36 is prima facie obvious.
Claim 37 is directed towards a method of inhibiting a bacterial RNA polymerase comprising contacting the bacterial RNA polymerase with a compound of claim 1. Ebright teaches a method of inhibiting a bacterial RNA polymerase comprising contacting the bacterial RNA polymerase with Ebright’s compound (Ebright, claim 57), and claim 37 is prima facie obvious.
Claim 38 is directed towards a method for inhibiting the growth of bacteria comprising contacting the bacteria with a compound of claim 1. Ebright teaches a method for inhibiting the growth of bacteria comprising contacting the bacteria with Ebright’s compound (Ebright, claim 58), and claim 38 is prima facie obvious.
Claim 39 is directed towards a method for treating a bacterial infection in a mammal comprising administering to the mammal an effective amount of the compound of claim 1. Ebright teaches a method for treating a bacterial infection in a mammal comprising administering to the mammal an effective amount of Ebright’s compound (Ebright, claim 59), and claim 39 is prima facie obvious.
Nonstatutory 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 1, 4-5, 9-10, 24, 26, and 36-39 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,447,502 (reference patent) in view of Heep.
Claims 1, 4-5, and 9 are directed towards a compound of formula (I):
α-β-γ,
wherein
α is a benzoxazino-rifamycin or a spiro-rifamycin
β is a bond or a linker
γ is a moiety that binds to the bridge-helix N-terminus target of a bacterial polymerase
Applicant’s elected species of
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is one such compound, comprising a moiety that binds to the bridge-helix N-terminus target of a bacterial RNA polymerase:
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connected by a covalent bond to the spiro-rifamycin moiety, rifabutin:
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The reference patent teaches the compound,
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(reference patent, claim 18).
The reference compound similarly comprises the identical moiety that binds to the bridge-helix N-terminus target of a bacterial RNA polymerase, connected by a covalent bond to a rifamycin moiety. The reference compound differs from applicant’s compound in that the rifamycin moiety is rifampin:
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One of ordinary skill in the art would be motivated to replace this rifampin moiety with a spiro-rifamycin moiety, such as rifabutin, because such spiro-rifamycins are known in the art to have generally greater antibacterial activity than non-spiro rifamycin compounds, and are more commonly used than rifamycins when addressing the growing problem of antibiotic-resistant bacteria (Heep, pg. 1497). Thereby, the replacement of the rifampin moiety with a rifabutin moiety and claims 1, 4-5, and 9 is obvious.
Claim 10 is directed towards a method of making a compound as described in claim 1 wherein the compound is prepared from precursors α-β’ and ‘β-γ, where β’ and ‘β are moieties that can react to form β.
The reference patent teaches a method of making the reference compound, wherein the compound is prepared from precursors X-α' and 'α-Y, where α' and 'α are moieties that can react to form α (reference patent, claim 14). As this is analogous to applicant’s process and claim 10 is obvious.
Claim 24 is directed towards a method of inhibiting one of the growth and viability of a bacterium via contacting the bacterium with the compound of claim 1. The reference patent teaches the inhibition of growth of a bacterium via contacting the bacterium with the reference compound (reference patent, claim 16), and claim 24 is obvious.
Claim 26 is directed towards a method of treating a bacterial infection comprising administering to a mammal the compound of claim 1. The reference patent teaches a method of treating a bacterial infection comprising administering to a mammal the reference compound (reference patent, claim 17), and claim 26 is obvious.
Claim 36 is directed to a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable vehicle. As the administration of a drug in a pharmaceutical composition with a pharmaceutically acceptable vehicle is standard practice, claim 36 is obvious.
Claim 37 is directed towards a method of inhibiting a bacterial RNA polymerase comprising contacting the bacterial RNA polymerase with a compound of claim 1. The reference patent teaches a method of inhibiting a bacterial RNA polymerase comprising contacting the bacterial RNA polymerase with the reference compound (reference patent, claim 15), and claim 37 is obvious.
Claim 38 is directed towards a method for inhibiting the growth of bacteria comprising contacting the bacteria with a compound of claim 1. The reference patent teaches a method for inhibiting the growth of bacteria comprising contacting the bacteria with the reference compound (reference patent, claim 16), and claim 38 is obvious.
Claim 39 is directed towards a method for treating a bacterial infection in a mammal comprising administering to the mammal an effective amount of the compound of claim 1. The reference patent teaches a method for treating a bacterial infection in a mammal comprising administering to the mammal an effective amount of the reference compound (reference patent, claim 17), and claim 39 is obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/ANTHONY JOSEPH SEITZ/Examiner, Art Unit 1629
