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 .
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.
Claims 15, 28 and 41 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.
This rejection has been withdrawn in view of the Amendment filed 12/31/2025.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7, 9-11, 13-16, 18 and 26-29 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Williams, III et al. US 12,076,328 B2.
This rejection has been withdrawn in view of the Amendment filed 12/31/2025.
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 1-3, 7, 9, 13, 14, 16, 26-29, 52 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Williams, III et al. US 12,076,328 B2, in view of Baltezor et al. 10,507,195 or Temtem et al. US 20170209372 A1.
Williams teaches a pharmaceutical composition comprising niclosamide, and optionally an excipient for inhalation. See Abstract and Claims. Compositions comprising up to 90% by weight of niclosamide is found in column 12, lines 40-49. Niclosamide includes a salt such as an ethanolamine or piperazine salt is found in column 12, lines 50-52. Niclosamide includes co-crystal of niclosamide may be used in the pharmaceutical compositions may include co-crystals of niclosamide with 2-aminothiazole, benzamide, isoniazid, acetamide, caffeine, urea, p-aminobenzoic acid, theophylline, nicotinamide, or isonicotinamide is found in column 12, lines 54-65. Naclosamide having the claims particle diameter is found in column 13. Nacloside particle having a high surface area, a low tapped density, or a low bulk density, including surface area of greater than 10 m2/g, greater than 25 m2/g, or greater than 50 m2/g; bulk density of the pharmaceutical compositions may be less than 1 g/mL, less than 0.5 g/mL, or less than 0.25 g/mL; and tapped density of the pharmaceutical compositions may be less than 0.1 g/cm3, 0.05 g/cm3, or 0.025 g/cm3. See column 13, last paragraph through column 14. The use of noclosamide for the treatment similar to that of the present claims is found in columns 16-17. The composition further comprises the claimed excipients/carriers. See columns 18-21. The claimed method is found in columns 22-24.
While Williams teaches the amount of niclosamide of about 90% w/w, Williams does not expressly teach the amount of at least 90% w/w.
Baltezor teaches a composition comprising particles including at least 95% by weight of an active agent, or a pharmaceutically acceptable salt thereof, wherein the particles have one or both of the following characteristics: (i) a mean bulk density between about 0.050 g/cm3 and about 0.15 g/cm3, and/or; (ii) have a specific surface area (SSA) of at least 18 m2/g. See Abstract and Claims. The particles have a mean particle size of between about 0.4 μm and about 1.2 μm. See column 5. Method for making the particle is found in columns 12-19.
Temtem teaches a composition comprising a particulate amorphous solid dispersion comprising 5 to 95% (w/w) of the pharmaceutically active compound and 95 to 5% (w/w) of the stabilizing agent. See paragraph 0019. Active compound including niclosamide is found in paragraph 0074.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to optimize the teaching in Williams to include at least 90% w/w of the active agent in the particle with the expectation of at least similar result in view of the teaching of Baltezor or Temtem. This is because Temtem teaches the desirability for having high drug load composition is known in the art, and this is because Temtem teaches including niclosamide in a composition having drug load of up to 95% is known and desired. This is because Baltezor teaches a composition with improved dissolution rate of a poorly water-soluble active agent, therefore, the composition is able to include at least 95% of active agent. See column 1. Therefore, one of ordinary skill in the art would have been motivated to, by routine experimentation making a composition that comprises at least 95% of niclosamide given the teaching of Williams in view of the teaching in Baltezor. This is because Williams teaches the desirability to obtain a composition with improved solubility for the delivery of niclosamide, this is because niclosamide is known in the art to suffer from low solubility. See column 2 in the Williams reference. Advantageously, Baltezor teaches a composition suitable for the delivery of a poorly water-soluble active agent, a composition that can comprise at least 95% of any known poorly water-soluble active agents in the art, a composition that can be delivered through different routes including pulmonary (see column 11), and a composition that provides improved solubility, dissolution, and bioavailability of a poor water-insoluble active agent.
Claims 1-4, 7, 9-11, 13-16, 18, 22, 24, 26-29 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. CN 1883266 A, in view of Baltezor et al. WO 2016197091 A1.
This rejection has been withdrawn in view of the Amendment filed 12/31/2025.
Response to Arguments
Applicant’s arguments filed 12/31/2025have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 10/09/2025 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615