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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/17/2025 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, 4, 6-9, 13-16 and 19-26 are rejected under 35 U.S.C. 103 as being unpatentable over in view of Holm et al. WO 2007/076874 A1 (Holm 1), in view of Holm WO 2006/000229 A2 (Holm 2) and Yoshinari et al. US 20020107420 A1.
Holm 1 teaches a tablet comprising solely inert pharmaceutically acceptable excipients, and when the tablet is subjected to a pharmaceutically acceptable liquid formulation e.g. containing the active substance, the tablet will due to its porosity - suck the liquid formulation into the tablet. Most surprising this loading of an inert tablet takes place within a relatively short period of time and is reproducible, i.e. the same amount of liquid formulation is sorbed when the same type and size of tablet and liquid formulation is used. See page 3, lines 5-14. Tablet comprising i) at least 60% w/w of a sorbent material, and ii) a disintegrant or a mixture of disintegrants, wherein the tablet in compressed form has a porosity of 45% v/v or more, and a loading capacity of at least 30% of a liquid substance or liquid composition. See pages 6-8. Sorbent material includes a sugar alcohol selected from the group consisting of sorbitol, xylitol, mannitol, maltitol, inositol, mannitol, and/or it may be a sugar selected from the group consisting of mono-, di- or polysaccharides including saccharose, glucose, fructose, sorbose, xylose, lactose, dextran, dextran derivatives, cyclodextrins. See page 12. Disintegrant such as microcrystalline cellulose, hydroxypropyl cellulose and other cellulose derivatives, croscarmellose sodium, crospovidone, polacrillin potassium, sodium starch glycolate, starch, pregelatinized starch, carboxymethyl starch in an amount between 0.1%-15% w/w is found in pages 13-14. Tablet further comprising binder and other additives is found in pages 16-17. Process for preparing compressible tablet and loading the tablet with liquid active composition is found in pages 19-20 and 36-37.
Holm 1 does not expressly teach δ-form D-mannitol, however, the use of δ-form D-mannitol in tablet composition is known in the art. See for example the teaching in Yoshinari, which teaches δ-form D-mannitol exhibits excellent compressibility which can be used as an excipient for direct compression, wet-granulation or dry-granulation. See paragraphs 0025-0026, 0030 and 0067. Examples 1-4 show compressed tablet comprising δ-form D-mannitol.
Thus, it would have been prima face obvious to one of ordinary skill in the art to, by routine experimentation select mannitol having δ-form D-mannitol as a tablet excipient including as a binding agent with the expectation to obtain a solid tablet dosage form useful in pharmaceutical art. This is because Yoshinari teaches δ-form D-mannitol has excellent compatibility and compressibility, it is remarkably useful as an excipient, and this is because Holm teaches the desirability to use mannitol as a tablet excipient.
Holm 1 further does not expressly teach the claimed tablet porosity of from 20% to 40%.
Holm 2 teaches a loadable inert tablet contains pharmaceutically acceptable excipients selected from the group consisting of fillers, diluents, binders, lubricants, glidants etc. Additives such as, e.g., pH adjusting agents, buffering agents, enhancers, wetting agents, solubilizing agents, surfactants, antioxidants etc. Holm 2 further teaches the inert tablet having a porosity of at least about 30% v/v in order to enable a suitable loading with a liquid. See pages 4-5.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to, by routine experimentation obtain an inert tablet having a porosity that falls within the claimed range in view of the teaching of Holm 2. This is because Holm 2 teaches an inert tablet having a porosity of at least 30% is known and useful in the art, and this is because Holm 1 teaches selecting a loadable carrier which provides tablets with porosities in the range of 30-90%, is applicable. Other materials than mentioned above may be applied as tablet core material, such as calcium carbonate, magnesium oxide preferable spray dried materials with satisfactory flowability and high specific surface area. The disintegration time of the tablets might be adjusted by addition of conventional tablet disintegrants and used in formulation of immediate release tablets as well as controlled release matrix tablets. See page 47.
Response to Arguments
Applicant’s arguments filed 12/17/2025 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