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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/15/2026 has been entered.
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, 41, 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 Temtem et al. US 20170209372 A1 and Hom-ma et al. US 6,274,174 B1.
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.
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 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.
It is noted that the cited references do not teach the claimed specific surface area of niclosamide. However, it is known in the art to increase specific surface area of a low water-soluble drugs to increase the drug bioavailability. See for example the teaching in Hom-ma, see Abstract: The present inventors have made studies for the purpose of establishing a process for preparing controlled-release preparations which can rapidly release 99% or more of a slightly soluble medicament (which has by itself shows a slow dissolution rate) in the upper part of the small intestine. As a result, the inventors have succeeded in establishing a process comprising carrying a slightly soluble medicament which has a slow intestinal dissolution rate on aggregates of the spherical microparticles of a multivalent metal alginate, in which each of the secondary particles (i.e., the aggregates) has a specific surface area ranging from 1 to 280 m2/g. This success leads to the accomplishment of the present invention. Hom-ma teaches conventional pharmaceutical preparations for oral administration which contains a slightly soluble medicament, the medicament shows a small dissolution rate in the digestive tract. Therefore, the amount of the dissolved medicament per a certain time of period is small, the absorption of the medicament through the digestive tract is delayed, and the amount of the medicament absorbed through the digestive tract per hour becomes small, resulting in slow absorption in a living body and a low bioavailability. In these situations, improvement in solubility of the slightly soluble medicament has been desired for effective manifestation of the efficacy and the quick-acting nature of the medicament. See column 1.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to, by routine experimentation optimize the teaching in Williams in view of the teaching in Hom-ma to obtain a niclosamide particle having a specific surface area that falls within the claimed range. This is because Hom-ma teaches a composition with improved dissolution rate of a poorly water-soluble active agent. Hence, one of ordinary skill in the art would have been motivated to, by routine experimentation making a composition comprises niclosamide with specific surface area that falls within the claimed range given the teaching of Williams in view of the teaching in Hom-ma. 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, Hom-ma teaches a composition suitable for the delivery of a poorly water-soluble active agent that provides improved solubility, dissolution, and bioavailability of a poor water-insoluble active agent.
Response to Arguments
Applicant’s arguments filed 05/15/2026 have 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.
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
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