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 . Claims included in the prosecution are claims 30, 31, 35, 38, 39, 41, 50 and 51.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/30/2026 has been entered.
Applicants' arguments, filed 04/30/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
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 30, 31, 35, 38, 39, 41, 50 and 51 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.
This is a new matter rejection.
Claim 30 recites a sub-inhibitory amount of zinc ionophore. The claim fails to comply with the written description requirement since this limitation is not supported in the specification. Paragraphs [0234]-[0237], [0246], and [0248] of the specification discloses a sub-inhibitory concentration of PBT2+ zinc chloride. The specification does not disclose wherein zinc ionophore alone may be present at a sub-inhibitory amount.
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.
1. Claims 30, 35, 38, 39, 41 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Huigens et al. (WO 2017/053696 A2, Mar. 30, 2017) (hereinafter Huigens) in view of Zhanel et al. (Subinhibitory antimicrobial concentrations: A review of in vitro and in vivo data, 1992) (hereinafter Zhanel).
Huigens discloses halogenated quinoline derivatives, such as compounds of Formula (I’):
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The halogenated quinoline derivates may be useful in preventing or treating a microbial infection (e.g., a bacterial infection) in a subject (abstract). RG and RE are each a halogen. RC may be H. RH may be
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, wherein RD and RB may each be H, RA may be a substituted or unsubstituted alkyl, and RK’ may be a substituted or unsubstituted C1-6 alkyl (claim 1). Halogens include chlorine (-Cl) (¶ [0066]). RA may be specifically Me (¶ [00124]). Examples of C1-6 alkyls include methyl (¶ [0046]). The compound may be administered concurrently with, prior to, or subsequent to, one or more additional pharmaceutical agents, which are different from the compound and may be useful as, e.g., combination therapies (¶ [00246]). Exemplary additional pharmaceutical agents include a tetracycline (e.g., doxycycline) (¶ [00247]). The bacterium may be a multidrug-resistant bacterium. The bacterium may be a Gram-positive bacterium. The bacterium may be a Streptococcus species, such as Streptococcus pneumoniae (¶ [00267]).
Huigens differs from the instant claims insofar as not disclosing wherein the zinc ionophore is administered to a subject in an amount that is subinhibitory to the bacterial infection in the absence of the antibiotic.
However, Zhanel discloses wherein antimicrobial activity is not an “all or none” effect. An increase in the rate and extent of antimicrobial action is usually observed over a wide range of antimicrobial concentrations. Subinhibitory antimicrobial concentrations are well known to product significant antibacterial effects, and various antimicrobials at subinhibitory concentrations have been reported to inhibit the rate of bacterial growth (abstract).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have administered the compound of Huigens in amount that is subinhibitory to the bacterial infection since the compound is useful in preventing or treating a microbial infection and a subinhibitory concentration is a known and effective concentration for antimicrobials to inhibit the rate of bacterial growth as taught by Zhanel.
In regards to instant claim 30 reciting wherein the zinc ionophore confers sensitivity of the bacterium to the antibiotic and increases the amount of zinc in the bacterium, the prior art discloses substantially the same compound as the claimed invention. Therefore, the compound of the prior art necessarily confers sensitivity of the bacterium to the antibiotic and increases the amount of zinc in the bacterium like the claimed invention.
2. Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Huigens et al. (WO 2017/053696 A2, Mar. 30, 2017) (hereinafter Huigens) in view of Zhanel et al. (Subinhibitory antimicrobial concentrations: A review of in vitro and in vivo data, 1992) (hereinafter Zhanel), and further in view of Jordan et al. (US 7,846,919, Dec. 7, 2010) (hereinafter Jordan), as evidenced by Barnham et al. (US 2008/0161353, Jul. 3, 2008) (hereinafter Barnham).
The teachings Huigens and Zhanel are discussed above. Huigens and Zhanel do not teach wherein the compound is in combination with a pharmaceutically acceptable zinc (II) salt.
However, Jordan discloses a composition for use in treating epithelial lesions formed of a combination of ingredients comprising 8-hydroxyquinoline and zinc bonded to said 8-hydroxyquinoline (claim 1). The zinc is provided in the composition as zinc chloride (claim 4).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have the compound of Huigens in combination with zinc chloride motivated by the desire to additionally treat epithelial lesions since the combination of an 8-hydroxyquinoline and zinc treats epithelial lesions as taught by Jordan.
As evidenced by Barnham, the compound of Huigens is 8-hydroxyquinoline derivative PBT 1033 (pages 9 and 65):
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3. Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Huigens et al. (WO 2017/053696 A2, Mar. 30, 2017) (hereinafter Huigens) in view of Zhanel et al. (Subinhibitory antimicrobial concentrations: A review of in vitro and in vivo data, 1992) (hereinafter Zhanel), Jordan et al. (US 7,846,919, Dec. 7, 2010) (hereinafter Jordan), and further in view of Nguyen et al. (Structures of the copper and zinc complexes of PBT2, a chelating agent evaluated as potential drug for neurodegenerative diseases, Nov. 4, 2016) (hereinafter Nguyen).
The teachings of Huigens, Zhanel, and Jordan are discussed above. Huigens, Zhanel, and Jordan do not disclose wherein the compound and the zinc (II) salt are in the form of a zinc (II) coordination complex.
However, Nguyen discloses Zn(PBT2)2Cl (Figure 5 motif B).
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Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Jordan discloses wherein the combination of an 8-hydroxyquinoline and zinc treats epithelial lesions. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to incorporated Zn(PBT2)2Cl as the halogenated quinoline derivative of Huigens since it is a known and effective 8-hydroxyquinoline in combination with zinc as taught by Nguyen.
Response to Arguments
Applicant’s arguments have been considered but are moot because new rejections necessitated by Applicant’s amendment have been made.
Conclusion
Claims 30, 31, 35, 38, 39, 41, 50 and 51 are rejected.
Claims 36 and 40 have been withdrawn.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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