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.
Claim 13 is 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.
Claim 13 recited the use of multi layered particle according to claim 1 comprising the steps of blending the particle with excipients and compressing to obtain a solid dosage form. Accordingly, claim 13 appears to be a method of making a solid dosage form, however, the phrase “use of multi layered article” appears to be a method of use. Further clarification is requested.
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 1-13 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over McNally et al. US 20190099379 A1, in view of Desai et al. WO 2008056200 A1 and Stevens et al. US 5,980,944.
McNally teaches a microencapsulated simethicone particles comprising: simethicone and a water-soluble coating, wherein the simethicone is about 50% by weight of the particle. See paragraphs 0006-0007. Paragraphs 0008-0010 disclose the process for coating the simethicone particle. Water-soluble coating includes, for example, gelatin, pectin, water soluble materials, combinations of water-soluble materials with water insoluble materials, whey protein isolate, or mixtures thereof. see paragraph 0014. The coating may be partially water soluble or pH sensitive, such that it does not dissolve in the oral cavity but is immediately released in the stomach or intestine. For example, the coating may incorporate a portion of water insoluble material such as a water insoluble polymer. Suitable water insoluble polymers include but are not limited to ethylcellulose, cellulose acetate, and polymethacrylates. Suitable pH dependent polymers include cellulose acetate phthalate, hydrocypropylcellulose phthalate, shellac, hydroxypropylcellulose succinate, anionic copolymers based on methacrylic acid and methyl methacrylate such as those sold under the tradename of Eudragit L100. See paragraph 0016. The coating may include a plasticizer or a surfactant. Suitable plasticizers include for example, glycerin, polyethylene glycol, propylene glycol, dibutyl sebecate, triethyl citrate, vegetable oils such as castor oil. Suitable surfactants include Polysorbate-80, sodium lauryl sulfate and dioctyl-sodium sulfosuccinate. The plasticizer may comprise from 1 percent to 30 percent by weight of the coating. The surfactant may comprise from 1 to 20 percent of the coating. See paragraph 0023. The microencapsulated simethicone particles may be used in various applications. For example, the inventive particles may be included in an oral dosage form, such as an orally disintegrating tablet, a capsule, a compressed tablet such as a chewable tablet a lozenge, a chewing gum or a gummy form. Alternatively, the particles may be included in orally dissolving granules. See paragraph 0025. In one embodiment, the microencapsulated simethicone particles are prepared by spray drying. The process comprises the steps of (a) forming a water coating solution, (b) combining simethicone and the water-soluble coating solution and forming an emulsion, and (c) spray drying the emulsion. Optionally, silicon dioxide may be added during spray drying as a flow agent. In various embodiments, the process may include the step of adjusting the pH of the water-soluble coating solution to a pH of 7. Optionally, an organic solvent may also be added to the spray drying solution. Suitable organic solvents may include ethanol, isopropanol, or acetone. In another embodiment, the microencapsulated simethicone particles are prepared by spray congealing. The process comprises the steps of (a) melting a suitable wax, lipid or combination of waxes; (b) combining the simethicone and mixing; and (c) spraying the particulates at a temperature which will solidify the particles and (d) collecting the microencapsulated particles. See paragraph 0041. Multiple coating layers is found in paragraphs 0043 and 0062 and Examples.
McNally does not expressly teach the claimed absorbent materials such as calcium or silicate.
Desai teaches a chewable tablets of simethicone, alone or with additional active ingredients (e.g., loperamide hydrochloride) and administered, for example, to treat diarrhea and act as an anti-gas/anti- flatulent. While tablets have been specifically named as a suitable or possible dosage form, other dosage forms, also may be made according to the present invention. These additional dosage forms include bi-layer or tri-layer tablets, tablet-in-tablet, film-coated tablets, effervescent tablets, dispersible tablets, chewable tablets, chewing gums, powders, granules, and capsules. See Abstract and Claims. Desai further teaches adsorbent material maybe one or more of powdered cellulose, microcrystalline cellulose, macrocrystalline cellulose, tribasic calcium phosphate, dibasic calcium phosphate, maltodextrin, precipitated silica, colloidal silica, starch, pregelatinized starch, hydroxypropyl cellulose, magnesium oxide, and magnesium hydroxide. The adsorbent material may be a material that adsorbs simethicone onto the surface of the adsorbent material. The ratio of the simethicone to the calcium silicate and at least one adsorbent material may be between 4:1 to 1:2 on a weight percentage basis. See pages 3 and 8-9.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to optimize the teaching of McNally to include an absorbent material such as calcium or silicate in view of the teaching of Desai with the expectation of at least similar results. This is because Desai teaches using absorbent material such as calcium or silicate for simethicone particle is known in the art, and this is because both Desai and McNally teach the desirability to prepare a simethicone particle useful for the preparation of orally disintegrating tablet.
McNally further does not teach the claimed coating that comprises a binder and a disintegrant.
Stevens teaches a solid oral dosage form comprising simethicone coating with a multilayer comprising a barrier (separating) layer and a layer comprising a binder and a disintegrant. See Abstract, Figures 1-4, and Examples. Barrier layer comprising the claimed polymer is found in column 4. Coating layer comprising a binder and a disintegrant can be found in columns 5-6.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to optimize the teaching in McNally in view of the teaching in Stevens with the expectation to obtain a solid oral dosage form useful for the delivery of simethicone useful for the treatment of gastrointestinal disorder similar to that of the present invention. This is because Steven teaches a multilayer solid oral dosage form wherein simethicone and the pharmaceutical are separated by a material substantially impermeable to simethicone is known in the art. See column 6.
Response to Arguments
Applicant’s arguments filed 01/23/2026 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.
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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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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