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 Objections
Claim 12 of the Amended claims filed 10/26/2023 is objected to because of the following informalities: Claim 12 followed by cancelled claim 12 and continued on with claim 13. The claims appear to have the right order from 1 through 20. Therefore, it appears that the cancelled Claim 12 is a typographical error. Appropriate correction is required.
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 2 and 10 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.
Claims 2 and 10 recited the phrase “selected from”. If Markush language was intended, the proper phrasing should read: selected from the group consisting of.
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.
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.
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.
Vergnault teaches a method of treating insomnia in a patient in need thereof, comprising administering a dosage form containing a drug substance useful in treating insomnia, the dosage form being adapted to release said drug substance after a lag time during which no, or substantially no, drug substance is released, the lag time being about at least one hour after administration of the dosage form. See page 3. Vergnault further teaches the pH of the gastric tract can differ markedly depending on whether a patient is in a fed or fasted state. Accordingly, to achieve a reliable pre-determined lag time, the release of said drug substance from the dosage form is preferably pH-independent. In a preferred composition, during the pendency of lag time any drug substance that is released is in such small amounts that effective blood plasma levels of the drug substance are not reached. Preferably, drug substance release is less than 10% by weight, more particularly less than 5%, still more particularly less than 2%, still more particularly less than 1%. See page 4. Ramelteon as an active agent is found in page 7, 5th paragraph. Dosage form with controlled release coatings is found in pages 8-9. Immediate release coating layer is found in page 10. Tablet with tablet core is found in page 11.
While Vergnault teaches ramelteon, there’s no express teaching of ramelteon in the example of tablet dosage from.
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.
It is noted that the cited references do not expressly teach the claimed coating order.
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.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to, by routine experimentation select an order of coating arrangement that fall within the claimed limitations with the expectation to obtain a dosage form suitable for the delivery of ramelteon useful for the treatment of sleeping disorder given the teaching in Vergnault, Perlman and Rariy. This is because it is known in the art to protect acid labile active agent from the stomach acid by providing dosage forms with a protective coating layer such as an enteric coating. This is because the Perlman reference teaches that 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. Therefore there is the need to prepare a dosage form that can deliver ramelteon for the treatment of sleeping disorder with improved dissolution rate, improved patient compliant with improved bioavailability. Furthermore, one of ordinary skill in the art would have been motivated to optimize the teaching in Vergnault in view of the teaching in Rairy to obtain a composition useful for the treatment of insomnia because of the references teach the desirability to obtain a pulsatile release composition with useful dosage structure to protect and provide improved dosage form for an acid labile active agent including ramelteon.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ROBERT A. WAX can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUSAN T TRAN/Primary Examiner, Art Unit 1615