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 23-25, 27, 29, 32, 34-36, 38, 42, 48-50, 53, 55 and 63-66 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This rejection has been withdrawn in view of Applicant’s Amendment filed 09/15/2025.
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 23, 24, 27, 29, 32, 35 and 42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang et al. CN 109497560 A.
Claims 23-25, 27, 29, 21, 34-36, 42, 48-50, 53, 55 and 63-66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tillotson et al. US 9,358,212 B2.
The above 102 rejections have been withdrawn in view of Applicant’s Amendment filed 09/15/2025.
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 23-25, 27, 29, 32, 34-36, 38, 42, 48-50, 53 and 63-66 are rejected under 35 U.S.C. 103 as being unpatentable over Tillotson et al. US 9,358,212 B2, in view of Tillotson et al. KR 20110128829 A (Tillotson ‘829).
Tillotson teaches an oral solid dosage form comprising at least three polyols and at least one active agent. See abstract and columns 11-12, 24 and 26. Polyols include mixture of mannitol, sorbitol and maltitol in an amount of from 80-99.5%, 0.5-20%, and 0.5-20% respectively is found in column 11, lines 23-35, and column 12, lines 63 through column 13. Solid dosage form having increase hardness values is found in column 24, lines 43-54. Dosage further comprising effervescent components is found in column 25, lines 33-59. Solid dosage having the claimed total weight in mg, friability, compression force and hardness in kP is found in column 28 and Examples. In some embodiments, an excipient system including 91.2 wt % mannitol, 2.3% sorbitol and 6.5 wt % maltitol has a hardness value of about 45 kP upon application of a 34 kN compression force. Such an excipient system may have a friability value of about 0.13%. In some embodiments, the moisture content of the solid dispersion may be less than about 8%, less than about 5%, less than about 3%, less than about 2%, less than about 1% or less than about 0.5%. In one embodiment of the present invention, the moisture content of the solid dispersion is about 0.3%. See columns 17-19.
Tillotson does not expressly teach the claimed ratio between the three polyols.
However, coprocessing at three polyols having the ratio that falls within the claimed range is known in the art. See for example the teaching in Tillotson ‘829. Specifically in the claims, where Tillotson teaches a solid dosage form of claim 35, wherein the solid dosage form disintegrates within 10 minutes. The method of claim 23, wherein the polyols comprise about 70 wt% to about 99.5 wt% of the first polyol, about 0.5 wt% to about 30 wt% of the second polyol, and about 0.5 wt% to about 30 wt% of the third polyol. The solid dosage form of claim 37, wherein the first polyol is mannitol, the second polyol is maltitol, and the third polyol is sorbitol. The solid dosage form of claim 37, wherein the first polyol is mannitol, the second polyol is lactitol, and the third polyol is sorbitol.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to, by routine experimentation select a ratio of mannitol, maltitol and sorbitol of at least 80:10:10 in view of the teaching in Tillotson ‘829 with the expectation of at least similar result. This is because Tillotson ‘829 teaches the use of mannitol in a ratio that falls within the claimed range, namely, 70-80%, sorbitol in the range that falls within the claimed range, namely, up to 20% and the third polyol in an amount within the claimed range, namely, up to 10%. This is because Tillotson ‘829 teaches mixing at least three polyols to obtain a compressed tablet is known in the art.
Response to Arguments
Applicant’s arguments filed 09/15/2025 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
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