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.
Claims 4 and 5 are 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.
This rejection has been withdrawn in view of the Amendment filed 12/19/2025.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6, 8-10, 12, 13, 15, 16, 18-24 and 28-33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Baek et al. EP 3556345 A1.
Claims 1-3, 6, 8-10, 12, 13, 15, 16, 18-24 and 28-33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bai et al. CN 110475544 A.
These rejections have been withdrawn in view of the Amendment filed 12/19/2025.
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, 6, 8-10, 12, 13, 15, 16, 18-24 and 28-33 are rejected under 35 U.S.C. 103 as being unpatentable over Baek et al. EP 3556345 A1 or Bai et al. CN 110475544 A, in view of Zhao et al. AU 2005287174 B2.
Baek teaches granules comprising an excipient, a disintegrant, and carbamate compound of Formula 1 or 2. The granules further comprising disintegrant and compressed to obtain an orally integrating tablet shows high hardness and low friability as well as fast disintegration rate, and also minimizes foreign body sensation and residual feeling. See page 3. Carbamate having the claimed formula compound is found on pages 4-5 and claims. Tablet having the claimed hardness and friability is found in page 10, first paragraph. The claimed excipients such as binder, disintegrant, diluent, and lubricant can be found in the Examples, and 8-9.
Bai teaches an orally disintegrating tablet comprising a carbamate compound of chemical formula 1, an isomer thereof, or a pharmaceutically acceptable salt, a solvate or a hydrate thereof as an active ingredient. See Abstract. Carbamate having the claimed formula 1 and formula 2 can be found in the Claims. Hydrophilic excipient, a second hydrophilic excipient sugar alcohol, and by the first hydrophilic excipient is selected from the group consisting of starch, microcrystalline cellulose, hydroxypropyl cellulose and lactose; and disintegrating agent are found in the Abstract. First hydrophilic excipient sugar alcohol selected from mannitol, sorbitol, xylitol, lactitol, maltitol, and erythritol. Disintegrating agent the (i) and (ii) is selected from sodium starch glycolate, crosslinked sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose and crospovidone can be found in the Examples. In one embodiment of the invention, the content of the urethane compound is 2.5% to 25 % of the total weight of the orally disintegrating tablet by weight. 65% to 90% by weight of the total weight in the one embodiment of the present invention, the content of the hydrophilic excipient is orally disintegrating tablet by weight. In one embodiment of the invention, the weight ratio of the first hydrophilic excipient with a second hydrophilic excipient is 2:1 to 10:1, and preferably from 4:1 to 8:1. 1% to 10% by weight of the total weight of disintegrating agent particles in one embodiment of the present invention, (i) in the orally disintegrating tablet of %, and preferably 2% to 5 wt %. In one embodiment of the present invention, the disintegrating agent in (ii) is mixed with 4% to 8% by weight of the total weight of 80% to 60% with 40 to 600 particles of particle size, and its content is the % of the orally disintegrating tablet. See Claims and Examples.
The references do not expressly teach the amount of the active ingredient that falls withing the claimed range.
Zhao teaches a pharmaceutical composition comprising a carbamate compound suitable for oral solid dosage form. The amount of the carbamate compound in the composition can vary widely depending on the type of composition, size of a unit dosage, kind of excipients, and other factors well known to those of ordinary skill in the art. In general, the final composition can 20 comprise, for example, from 1.0% percent by weight (% w) to 90 % w of the carbamate compound, preferably 10 % w to 75 % w, with the remainder being the excipient or excipients. Pharmaceutical formulations for oral administration can be formulated using pharmaceutically acceptable carriers well known in the art in dosages 25 suitable for oral administration. Such carriers enable the pharmaceutical formulations to be formulated in unit dosage forms as tablets, pills, powder, dragees, capsules, liquids, lozenges, gels, syrups, slurries, suspensions, etc. suitable for ingestion by the patient. See page 53.
Thus, it would have been prima facie to one of ordinary skill in the art to, by routine experimentation select an amount of active ingredient that falls within the claimed range given the teaching in Zhao. This is because Zhao teaches an amount of the carbamate compound that falls within the claimed range is known in the art, and this is because both of the primary references teach the amount of active ingredient that falls within the lower range of the claimed amount.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Baek et al. EP 3556345 A1 or Bai et al. CN 110475544 A, in view of Zhao et al. AU 2005287174 B2 and Kasu et al. WO 2007049292 A1.
The references are only deficient in the teaching of the particle diameter of the active ingredient.
Kasu teaches a compressed tablet composition comprising an active agent having D90 of less than 50 µm. See Abstract. Thus, it would have been prima facie obvious to one of ordinary skill in the art to optimize the tablet composition of Baek and Bai to include carbamate compound in the form of a granule having a particle diameter falls within the claimed range in view of the teaching of Kasu. This is because Kasu teaches the advantageous results in having active agent in granule size within the claimed range, including improved in absorption, dissolution rate, and bioavailability.
Response to Arguments
Applicant’s arguments filed 12/19/2025 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.
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