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 .
Status of Application
Receipt of Applicant’s remarks and amended claims filed on May 13, 2026 is acknowledged.
Claims 8, 13-16, and 24-30 are pending in this application.
Claims 8, 13, 14, 15, and 16 have been amended. Claims 1-7, 9-12, 17-23 have been cancelled.
Claims 24-30 are new.
All pending claims are under examination.
Withdrawn Objections/Rejections
Claim Objections
The objection to claim 11 under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim has been withdrawn in view of the cancellation of the claim.
Claim Rejections - 35 USC § 112
The rejection of claims 1-16 and 19-22 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement because the specification does not describe any species of the instantly claimed clofazimine polymorph, derivative, or analogues, thus, it does not describe a sufficient number of species as to convey possession of the entire genus encompassed has been withdrawn in view of the cancellation of the derivatives and analog from the claims.
The rejection of claims 2, 5, 8, 9, 11, 12, 19, and 22 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 because:
claim 2 recites an optional embodiment of a “band” has been withdrawn in view of the cancellation of the claim;
claim 5 recites “further comprising an emulsifying agent, wherein the content of the emulsifying agent is less than 50% w/w, and greater than 20% w/w water” and it is unclear if the emulsifying agent is greater than 20% water or the composition is 20% water has been withdrawn in view of the cancellation of the claim;
claim 8 recites “further comprising, wherein the content…” however, no additional component is recited has been withdrawn in view of the amendment to the claim to be an independent claims and the cancelation of “further comprising” language;
claim 9 recites “emulsion or suspensions with an average diameter of most about 1 mm” and it is unclear how an emulsion or suspension can have a particle size and if said diameters are about 1 mm or if the diameters are at most 1 mm has been withdrawn in view of the cancellation of the claim;
in claim 11, it is unclear how the composition is in the form of a suspension and gel (claim 7), foam, aerosol, or spray (claim 8), emulsion (claim 9) at the same time has been withdrawn in view of the cancellation of the claim;
claim 12 “recites wherein the composition is a suspension of clofazimine, hypersonic saline 3-7%, sodium bicarbonate, bismuth, gallium, or amino acids”. The type of composition is listed in the alternative, therefore, it is unclear if the composition can be merely a suspension of sodium bicarbonate, for example has been withdrawn in view of the cancellation of the claim;
claim 19 recites use for a composition but no active method steps are recited and therefore, it is not clear what the metes and bounds of the claim are has been withdrawn in view of the cancellation of the claim; and
claim 22 recites the broad recitation “percentage of 50-98%” and “geometric standard deviation <2.2”, and the claim also recites “preferably 60-90%” and “preferably <1.8” which is the narrower statement of the range/limitation has been withdrawn in view of the cancellation of the claim.
Claim Rejections - 35 USC § 101
The rejection of claim 19 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter has been withdrawn in view of the cancellation of the claim.
Claim Rejections - 35 USC § 102
The rejection of claims 1-7, 11-12, and 14-15 under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (WO 2021209025) has been withdrawn in view of the cancellation of claims 1-7 and 11-12 and the amendment to claims 14-15 to change the dependency to claim 8.
The rejection of claims 1-3 under 35 U.S.C. 102(a)(1) as being anticipated by Walter et al. (US 11,572,588) has been withdrawn in view of the cancellation of claims 1-3.
Claim Rejections - 35 USC § 103
The rejection of claims 1-4 and 10-11 under 35 U.S.C. 103 as being unpatentable over Barry et al. (US 5,610,198) has been withdrawn in view of the cancellation of the claims.
The rejection of claims 1-7, 11-13, and 14-15 under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2021209025) has been withdrawn in view of the cancellation of claims 1-7 and 11-12 and the amendment to claims 14-15 to change the dependency to claim 8.
The rejection of claim 9 under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2021209025) as applied to claims 1-7, 11-12, and 14-15 above, and further in view of Danaei et al. (Impact of Particle Size and Polydispersity Index on the Clinical Applications of Lipidic Nanocarrier System, Pharmaceutics, Published May 18, 2018) has been withdrawn in view of the cancellation of the claim.
The rejection of claim 16 under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2021209025) as applied to claims 1-7, 11-12, and 14-15 above, and further in view of Hofmann et al. (WO 2021/222740) has been withdrawn in of the amendment to claim 16 to change the dependency to claim 8.
The rejection of claims 20 and 22 under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 202109025) as applied to claims 1-7, 11-12, and 14-15 above, and further in view of Burger et al. (Formulation of Natural Oil Nano-Emulsion for the Topical Delivery of Clofazimine, Artemisome, and Decoquinate, Pharm Res (2018) 35:186) has been withdrawn in view of the cancellation of the claims.
The rejection of claim 21 under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 202109025) Burger et al. (Formulation of Natural Oil Nano-Emulsion for the Topical Delivery of Clofazimine, Artemisome, and Decoquinate, Pharm Res (2018) 35:186) as applied to claims 1-7, 11-12, 14-15, 20 and 22 above, and further in view of Rensburg (Formulation and Topical Delivery of liposomes and proliposomes containing clofaziminie, November 2016) has been withdrawn in view of the cancellation of the claims.
Maintained and Modified Rejections
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.
Claims 8, 13-15, and 24-30 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2021209025) in view of Beck et al. (US 2010/0093691).
Wang discloses a pharmaceutical composition comprising clofazimine, at least one solubilizers and optionally at least one stratum corneum penetration enhancer, where the composition is formulated for topical administration (Abstract).
The recitation of “for treatment of dermal infections with Mycobacterium ulcerans” is regarded as future intended use of the topical pharmaceutical composition.
Embodiments of topical formulations including aerosols and sprays (paragraph 00131).
Regarding claim 13, Wang does disclose dosage levels of the formulation can range from 0.001 mg/kg to about 1,000 mg/kg (page 0146). It is additionally disclosed that the clofazimine can be present in the formulation is the range of 0.001% to about 10% of the total weight of the composition (paragraph 0063).
Regarding claim 14, Figure 6 discloses clofazimine formulations with pH ranges from 6 to 9.5.
Regarding claim 15, example 30 discloses the use of a buffer salt solution.
Regarding claims 24-25, dosage levels on the order of from 1 mg to about 100 mg/kg of body weight per administration are useful in the treatment of a disease (paragraph 00146).
Regarding claim 26, clofazimine is disclosed to be insoluble in water and slightly soluble in ethanol (Table 5 and Table 7). Therefore, the aqueous or ethanolic solution would be have particulate clofazimine.
Regarding claim 27, Table 11 discloses preparation of clofazimine solutions.
Regarding claim 28, Clofazimine is disclosed to have anti-mycobacterial activity by binding preferentially to mycobacterial DNA, thereby inhibiting DNA replication and cell growth (paragraphs 0003-0004), therefore treating a mycobacterial infection.
Regarding claims 29-30, the topical formulation can additionally comprise a second active agent, examples include rifamycins and bacitracin (combination).
Wang does not disclose the aerosol or spray comprises hydrocarbon propellants, nonpolar hydrocarbons, ethanol, acetone, hexadecyl alcohol, glycol eithers, polyglycols, or a combination thereof.
Beck discloses topical formulations used to treat microbial infections (abstract). The bacteria to be treated include mycobacterium ulcerans (paragraph 0564).
The topical formulations can be a spray. Constituents include non-aqueous solvents including ethanol (paragraph 0780).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have prepared the topical spray using any conventionally recognized method within the art. Applicant’s attention is directed to MPEP 2141.03 which discloses The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the relevant time. Factors that may be considered in determining the level of ordinary skill in the art may include: (A) "type of problems encountered in the art;" (B) "prior art solutions to those problems;" (C) "rapidity with which innovations are made;" (D) "sophistication of the technology; and" (E) "educational level of active workers in the field. In a given case, every factor may not be present, and one or more factors may predominate." In re GPAC, 57 F.3d 1573, 1579, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995); Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962, 1 USPQ2d 1196, 1201 (Fed. Cir. 1986); Environmental Designs, Ltd. V. Union Oil Co., 713 F.2d 693, 696, 218 USPQ 865, 868 (Fed. Cir. 1983).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2021209025) in view of Beck et al. (US 2010/0093691) as applied to claims 8, 13-15, and 24-30 above, and further in view of Hoffman et al. (WO 2021/22740).
The teachings of Wang and Beck are discussed above.
Wang and Beck do not explicitly disclose the osmolality of the composition.
Hofmann discloses clofazimine composition in the form of a solution, suspension, or a dry powder. The composition can have an acceptable carrier and/or excipient (paragraph 0011).
The clofazimine is present in the amount of 1mg to 30 mg per dose (paragraph 0014).
Regarding claim 16, the osmolality of the formulation can be adjusted based on the type of formulation, for example, a hypertonic or hypotonic solution or suspension (paragraph 0040).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have prepared a formulation having different osmolality’s based on their intended function and type of formulation. Applicant is reminded that where the general conditions of the claims are met, burden is shifted to applicant to provide a patentable distinction. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454 105 USPQ 233,235 (CCPA 1955).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
