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 § 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over JP 6166859 B2 (JP 859), in view of Ohkura et al. US 5,554,439.
JP 859 a process for producing a taste-masked powder comprising an active pharmaceutical ingredient (API) and silica particles. API powders are core particles that contain an active pharmaceutical ingredient (API) with an undesirable taste. API core particles have a much larger particle size than silica particles. The API core particles can have a volume average median particle size in the range of, for example, 1 μm to 200 μm, 5 μm to 150 μm, or 10 μm to 100 μm. The API core particle is composed of a plurality of particles having a narrow particle size distribution. This is because API core particles having a broad size distribution including both microparticles and coarse particles are more likely to agglomerate during mixing and coating. See Abstract. JP 859 further teaches coating with a softer and more variable material with flaking and smears should also be used instead of coating with nanoparticles, as one or both of the above factors can cause a decrease in cohesion. Such coating comprising materials such as magnesium stearate, stearic acid, leucine, amino acids, and other materials commonly used for inhalation applications that impart dispersibility through hydrophobic and / or low adhesion materials. You may do it. See, for example, US Pat. No. 6,475,523, which includes a comprehensive list of surfactant molecules, the disclosure of which is incorporated herein by reference. Thus, such materials replace silica or nano-sized discrete particles with variable / flaky materials. The decrease in cohesion is caused by a decrease in the surface energy of the dispersion and may also be due to a reduction in surface roughness resulting from a softer material filling the rough voids resulting in a smoother surface. The claimed coating polymers and the claimed active agents are found in the Examples. Coating polymer solution comprising silica particles are found in the Examples.
JP 859 does not expressly teach film coating comprising the claimed flaky material such as potassium aluminum silicate, fine silicon dioxide, aluminum silicate, and magnesium aluminum silicate. However, the use of such materials in a film coating is known in the art.
Ohkura teaches a coating composition comprising a liquid medium containing a titanium dioxide pigment and a coating film formation resin said titanium dioxide pigment being in the form of flaky or fin-like small pieces of silicon dioxide covered by titanium dioxide and having a diameter of 1 to 300 microns and a thickness of 0.001 to 1 micron, a considerable portion of said silicon dioxide being dissolved out from said titanium dioxide-coated silicon dioxide small pieces. See Abstract. Column 2 shows flake like or fin like silicon dioxide coated with pigment and having the claimed diameter and thickness ratio.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to include flaky, pigment, and silica materials in view of the teaching in Ohkura with the expectation to obtain a coating useful in pharmaceutical art. This is because the Okura reference teaches the use of flaky silicon dioxide coated with titanium dioxide in a coating composition is known and desired in pharmaceutical art, and this is because the JP 859 teaches the desirability for adding flaky material into the coating composition to obtain a film coating layer useful for the delivery of a wide variety of active agents. Therefore, one of ordinary skill in the art would have been motivated to, by routine experimentation select to include the flake like silicon dioxide cover with titanium dioxide in a coating composition with the expectation of at least similar result.
Response to Arguments
Applicant’s arguments filed 02/19/2026 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.
Pertinent Arts
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jones is cited for the teaching of a coated perlite flakes having particle size of up to 50 µm.
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.
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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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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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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