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 .
Election/Restrictions
Applicant’s election without traverse of Group III and lactose as a specie (Claims 28, 29, 33-35, 37-47, 55 and 56) in the reply filed on 09/25/2025 is acknowledged.
Claims 1, 3, 5, 6, 8-11, 15, 21, 23-27, 51 and 52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/25/2025.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 28, 29, 33-35, 37, 38, 40, 41, 47, 55 and 56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moon et al. US 20080305168 A1.
This rejection has been withdrawn in view of the Amendment filed 04/16/2026.
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 39 and 42-46 are rejected under 35 U.S.C. 103 as being unpatentable over Moon et al. US 20080305168 A1, in view of Bertelsen et al. CN 101365426 B.
This rejection has been withdrawn in view of the Amendment filed 04/16/2026.
Claims 28, 29, 33-35, 37-41, 45-47 and 55-57 are rejected under 35 U.S.C. 103 as being unpatentable over Day et al. WO 2010028101 A1, in view of Berkland et al. US 10,398,649 B2 and Moon et al. US 20080305168 A1.
Day teaches a tablet comprising particles of cetirizine:polyol complex, and tablet matrix materials. See Abstract, and pages 4-6. Day further teaches tablet including orally disintegrating tablet. In such embodiments the cetirizine-polyol complex of the present invention is mixed with a carrier and formed into such a tablets. In one embodiment, the orally disintegrating tablet meets the criteria for Orally Disintegrating Tablets as defined by the draft Food and Drug Administration guidance, as published in April 2007, incorporated herein by reference. In one embodiment the orally disintegrating tablet meets a two-fold definition for orally disintegrating tablets including the following criteria: 1) that the tablet is one which contains medicinal substances and which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue and 2) be considered a solid oral preparation that disintegrates rapidly in the oral cavity, with an in-vitro disintegration time of approximately 30 seconds or less, when based on the United States Pharmacopeia (USP) disintegration test method for the specific medicinal substance or substances. In embodiments where orally disintegrating tablets are prepared, the tablet matrix containing a carrier and the cetirizine:polyol complex are shaped in a preformed mold or blister. In one embodiment, the orally disintegrating tablets are prepared via a lyophilization process. Suitable carriers for a tablet prepared via a lyophilization process include, but are not limited to, lactose such as lactose monohydrate and dextrose such as dextrose monohydrate. Gums or viscosity modifying agents (such as xanthan gum, hypromellose, locust bean gum, sodium alginate, and carrageenan) may also be added to the matrix. Other materials such as binders, sweeteners, and acidulants may also be added to the matrix. In one embodiment of preparing such a tablet utilizing lyophilization, the cetirizine:polyol granule is mixed with the matrix carrier materials and a lyophilization solvent, introduced into a mold or blister, and freeze-dried and packaged or sealed. See pages 8-9. Tablet includes swellable erodible hydrophilic materials such as gellan gum is found in pages 10-11.
Day does not expressly teach a gelling time of the swellable tablet.
Moon teaches a tablet-type oral care composition which is prepared by compressing porous plastic granules consisting essentially of a material for porous plastic granules, a binder, a gelling agent, a water penetration enhancer, an anti-adhesive agent to teeth and a humectant and undergoes in-situ gelling by water or saliva in oral cavity. See paragraph 0015. The prepared tablet-type oral care formulation according to the present invention undergoes in-situ gelling within 30 seconds by saliva in the oral cavity. See paragraphs 0045 and 0075. Tables 6-8 show gelling time and friability that fall within the claimed ranges. The use of gellan gum, lactose, microcrystalline cellulose and other tablet aids are found in pages 3-6.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to optimize the teaching in Day in view of the teaching in Moon with the expectation of at least similar result, namely, an oral disintegrating tablet useful for the delivery of drug via oral mucosa. This is because both Moon teaches an orally disintegrating tablet having the claimed gelling time is known in the art, and this is because Day teaches the desirability for preparing an orally disintegrating tablet comprising gelling agent and the desirability to obtain tablet that disintegrating rapidly in the oral cavity.
It is noted that while Day teaches cetirizine in particle form, Day does not teach the claimed particle size.
However, drug particle having the claimed particle size is known in the art. See for example the teaching in Berkland. The teaching of a sustained release drug particle comprising active ingredient having a mean particle diameter ranging from 150 µm to 250 µm is found in columns 3-4. Berkland further teaches the particles having a diameter with no more than a 10% standard deviation from the mean particle diameter. See Claims.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to optimize the teaching in Day to include particle size range within the teaching in Berkland with the expectation to obtain a composition suitable for the delivery of active agent via buccal mucosa.
Claims 43 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Day et al. WO 2010028101 A1, in view of Berkland et al. US 10,398,649 B2 and Moon et al. US 20080305168 A1, and further in view of Bertelsen et al. CN 101365426 B.
Bertelsen teaches a calcium-containing compound pre-compacted composition obtained by roller compaction and is suitable for use in the further processing of the pre-compacted material into composition like e.g. tablets and chewable tablets. See abstract and description. Calcium including calcium citrate is found in paragraphs 0020 and 0030. The composition further comprising calcium-containing compound is in the form of a direct compression. The precompacted composition comprising Sturcal L and xylitol, SturcalL, mannitol, Sturcal L and maltitol, Tricafos Tricafos P and P and xylitol, mannitol, Tricafos, maltitol, Tricafos A and xylitol, Tricafos A and mannitol, Tricafos A and maltitol. The composition further comprising organic acid, and lacose including alpha-lactose. See paragraphs 0174-0184.
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 Day to include other tablet excipients and calcium supplement in view of the teaching in Bertelsen with the expectation of at least similar result. This is because Bertelsen teaches the use of calcium and lactose and organic acid in a chewable tablet in known in the art. This is because Bertelsen teaches the use of alpha-lactose and calcium citrate in a chewable tablet to improve taste and porous structure. Similarly, Day teaches a chewable tablet that comprises lactose and calcium and organic acid. Therefore, a skill artisan would have been motivated to obtain a gellable tablet of the claimed invention given the teachings in Moon and Bertelsen.
Response to Arguments
Applicant’s arguments filed 04/16/2026 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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