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 1-20 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.
The amended claim 1 inserting the limitation “wherein a weight ratio of the drug-containing immediate-release shell to the drug-containing delayed-release tablet core is in a range from 4:1 to 12:1” in lines 5-6. It is not quite clear if the limitation is referring to the active ingredients alone or the entire composition, namely, the immediate release shell and the delayed-release core, respectively. This is confusing in view of the limitations recited in claims 6, 9 and 20. Here, claim 6 is referring to the active ingredients alone: “wherein a content ratio of active ingredients in the drug-containing immediate-release shell to the active ingredients in the drug-containing delayed-release tablet core is 1:1-3:1”. Claims 9 and 20 recited limitations similar to that of claim 1. Therefore, clarification is requested.
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 1-5, 7, 8, 10-14 and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rariy et al. CA 2590802 A1.
This rejection has been withdrawn in view of the Amendment filed 04/27/2026.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Vergnault et al. CA 2585910 C, in view of Perlman et al. US 20090105490 A1 and Rariy et al. CA 2590802 A1.
This rejection has been withdrawn in view of the Amendment filed 04/27/2026.
Claims 1-14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rariy et al. CA 2590802 A1, in view of Grenier et al. US 2008/0057123 A1.
Rariy teaches a pulsatile release dosage form comprising a pulsatile release of active ingredients and coating the active ingredients with polymers chosen to release the second and any further pulses at specific time points. This embodiment of the invention allows for the administration of a dosage form which provides a first release (pulse) of active ingredient, followed by a desired delay before a second pulse of active ingredient. The polymers are chosen in such a way as to deliver the secondary pulses at chosen time intervals. See page 21. Each dosage unit comprises two or more compressed tablets, or may be comprised of a plurality of beads, granules or particles, providing that each dosage unit has a different drug release profile. The immediate release dosage unit releases drug substantially immediately following oral administration to provide an initial dose. The delayed release dosage unit releases drug approximately 3 hours to 14 hours following oral administration to provide a second dose. Finally, an optional second delayed release dosage unit releases drug about 2 hours to 8 hours following the release of the second dose, and is typically 5 hours to 18 hours following oral administration. See paged 22-23. Pages 23-24 disclose arrangement of delayed release core, intermediate coating layer, enteric layer and immediate release layer in different orders. Enteric polymer is found in pages 25-27. Immediate release coating layer is found in page 27. Separating layer comprising stomach soluble polymer is found in pages 28-29. Example 2 shows tablet core coated with a separating or seal coating layer, and an enteric coating layer onto of the coated core. Coating weight gain is found in the Examples, and pages 33-35. Teaching that falls within the claimed coating layers arrangement is found Example 7.
Rariy is only deficient in the teaching of the weight ratio of the drug-containing immediate release shell to the drug-containing delayed release core. However, such teaching is known in the art. See for example the teaching in Grenier in Table 4, which teaches a ratio between the coat and core is about 6:1.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to optimize the teaching in Rariy in view of the teaching in Grenier to obtain the claimed invention. This is because Grenier teaches a controlled release tablet dosage form having the claimed weight ratio between the delayed core and the immediate release coating is known in the art. Therefore, one of ordinary skill in the art would have been motivated to, by routine experimentation select a weight ratio that falls within the claimed range in view of the teaching of Grenier to obtain a composition useful for the delivery of active agent at a predetermined rate of release. This is because Grenier teaches a dosage form useful for the delivery of a wide variety of active agents, and because Grenier teaches that it is well known and desired in pharmaceutical art to obtain a pulsatile release dosage form that offered a controlled release of active agent until the formulation reaches the absorption window. See paragraphs 0003-0008.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Perlman et al. US 20090105490 A1, in view of Rariy et al. CA 2590802 A1 and Grenier et al. US 2008/0057123 A1.
Perlman teaches a method of treatment of insomnia using a composition comprising ramelteon and at least one pharmaceutically acceptable excipient. See Abstract and paragraph 0016. Perlman teaches the rate of dissolution of an active ingredient in a patient's stomach fluid can have therapeutic consequences since it imposes an upper limit on the rate at which an orally-administered active ingredient can reach the patient's bloodstream. The rate of dissolution is also a consideration in formulating syrups, elixirs and other liquid medicaments. The solid state form of a compound may also affect its behavior on compaction and its storage stability. See paragraph 0006. Methods of administration of a pharmaceutical composition of the present invention may comprise administration in various preparations depending on the age, sex, and symptoms of the patient. The pharmaceutical compositions can be administered, for example, as tablets, pills, powders, liquids, suspensions, emulsions, granules, capsules, suppositories, injection preparations (solutions and suspensions), and the like. When the pharmaceutical composition comprises any one of the crystalline ramelteon forms of the present invention, a liquid pharmaceutical composition is a suspension or emulsion, wherein ramelteon retains its crystalline form. See paragraph 0084. Tablets can be further coated with commonly known coating materials such as sugar coated tablets, gelatin film coated tablets, tablets coated with enteric coatings, tablets coated with films, double layered tablets, and multi-layered tablets. Capsules can be coated with shell made, for example, from gelatin and optionally contain a plasticizer such as glycerin and sorbitol, and an opacifying agent or colorant. See paragraph 0096.
Perlman does not expressly teach the claimed coating order and the claimed ratio of coating layers.
Rariy teaches a pulsatile release dosage form comprising a pulsatile release of active ingredients and coating the active ingredients with polymers chosen to release the second and any further pulses at specific time points. This embodiment of the invention allows for the administration of a dosage form which provides a first release (pulse) of active ingredient, followed by a desired delay before a second pulse of active ingredient. The polymers are chosen in such a way as to deliver the secondary pulses at chosen time intervals. See page 21. Each dosage unit comprises two or more compressed tablets, or may be comprised of a plurality of beads, granules or particles, providing that each dosage unit has a different drug release profile. The immediate release dosage unit releases drug substantially immediately following oral administration to provide an initial dose. The delayed release dosage unit releases drug approximately 3 hours to 14 hours following oral administration to provide a second dose. Finally, an optional second delayed release dosage unit releases drug about 2 hours to 8 hours following the release of the second dose, and is typically 5 hours to 18 hours following oral administration. See paged 22-23. Pages 23-24 disclose arrangement of delayed release core, intermediate coating layer, enteric layer and immediate release layer in different orders. Enteric polymer is found in pages 25-27. Immediate release coating layer is found in page 27. Separating layer comprising stomach soluble polymer is found in pages 28-29. Example 2 shows tablet core coated with a separating or seal coating layer, and an enteric coating layer onto of the coated core. Coating weight gain is found in the Examples, and pages 33-35. Teaching that falls within the claimed coating layers arrangement is found Example 7.
Grenier teaches a ratio between the coat and core is about 6:1. See Table 4.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to optimize the teaching in Perlman in view of the teaching in Rariy and Grenier to obtain the claimed invention. This is because both Rariy and Grenier teach an oral dosage form useful for the delivery of a wide variety of active agents at a controlled release rate until the formulation reaches the absorption window.
Response to Arguments
Applicant’s arguments filed 04/27/2026 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.
The Declaration under 37 CFR 1.132 filed 04/27/2026 is sufficient to overcome the rejection of claims 1-20 based upon Bergnault et al. in view of Perlman and Rariy et al.
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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