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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 7-17 and 19-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,156,944 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘944 patent discloses an oral pharmaceutical composition comprising, a therapeutically effective amount of a natural plant alkaloid or acceptable salt thereof, pharmaceutically acceptable excipients, and optionally at least one biologically active amino acid, wherein: the natural plant alkaloid or acceptable salt thereof comprises 1.5 mg to 3.0 mg cytisine or an acceptable salt thereof, the pharmaceutically acceptable excipients comprise cellulose powder in an amount of 5.0% to 92.5% by weight of the oral pharmaceutical composition, calcium sulphate in an amount of 5.0% to 92.5% by weight of the oral pharmaceutical composition, silica colloidal in an amount of 0.5% to 3.0% by weight of the oral pharmaceutical composition, and magnesium stearate in an amount 0.5% to 3.0% by weight of the oral pharmaceutical composition, with the cellulose powder and the calcium sulphate representing 64.5% to 97.5% by weight of the oral pharmaceutical composition, the cytisine or acceptable salt thereof is composed of particles, at least 90% of which are of not more than 100 μm in diameter, the oral pharmaceutical composition has a level of cytisine dissolution such that not less than 75% of the cytisine or acceptable salt thereof has dissolved after 45 minutes, the oral pharmaceutical composition has a uniform distribution of the natural plant alkaloid or acceptable salt thereof with no deviations out of ±5.0% of an average alkaloid content, and the oral pharmaceutical composition is lactose-free. Tablet or capsule is found in claim 2. Composition comprising L-carnitine or tryptophan or combination thereof is found in claim 3.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to obtain the claimed invention given the claims of the ‘944 patent. This is because the ‘944 patent discloses a composition similar to that of the present invention, namely, an oral pharmaceutical composition comprising a natural plant alkaloid and a cellulose powder and calcium sulphate.
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 7-13, 17-24 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Bhatt et al. WO 2011/064797 A2 or Klepczynska et al. EP 2957280 A1, in view of Chan et al. US 2005/0123502 A1.
Bhatt teaches a tablet or capsule dosage form comprises plant alkaloid such as galantamine or pharmaceutically acceptable salt in micronized particle form having a D90 particle size of less than 100 µm. See abstract, claims, and pages 12-14. Galantamine in a dose range from 8 mg to 24 mg is found on page 14, third paragraph. Bhatt further teaches a dosage form further comprises excipients such as cellulose in an amount ranging from 20% to 80% by weight (pages 14-15); diluent such as calcium in an amount ranging from 10% to 60% by weight (page 20); colloidal silicon in an amount up to 3.0% by weight (page 21); and magnesium stearate in an amount up to 3% (page 21). Film coated tablet is found in the Abstract and the Claims.
Klepczynska teaches a tablet composition comprising cytisine in particle form having D90 below 80 µm. See abstract and paragraph 0021. The tablet further comprises powder cellulose, silicone dioxide, and magnesium stearate in the claimed amount. See paragraphs 0025-0029. Tablet comprising 1.5 mg of cytisine is found in claim 10.
Both of the cited references do not expressly teach excipients include calcium sulphate. Chan teaches an oral composition comprising nicotine active such as lobeline. See abstract and paragraph 0013. The composition is in the form of table or capsule comprising excipients including binder, disintegrant, glidant, and filler. Filler includes calcium sulphate in an amount between 50% and 99%.
Thus, it would have been prima facie obvious to one of ordinary skills in the art at the time the invention was made to, by routine experimentation include calcium sulphate in an amount that falls within the claimed range with the expectation of at least similar result. This is because Chan teaches the use of calcium sulphate as an excipient in oral dosage forms is known in the art, this is because Chan teaches the use of calcium sulphate as an excipient useful for dosage forms comprising plant alkaloid, and this is because Blatt and Klepczynska teach oral dosage forms that comprise excipients known in the art.
Claims 7-13, 17-24 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Bhatt et al. WO 2011/064797 A2 or Klepczynska et al. EP 2957280 A1, in view of Chan et al. US 2005/0123502A1, further in view of Bull et al. US 2011/0098265 A1 and Bieley US 2010/0021570 A1.
Bhatt or Klepczynska is relied upon for the reasons stated above. While the inclusion of amino acid is optional, and in the case that Applicant amending the claims to include amino acid. The references do not expressly teaches the inclusion of amino acid, as well as the use of alkaloid for the treatment of substance dependency. However, the use of the claimed alkaloid for the treatment of substance abuse is known in the art. See for example the teaching in Bull and Bieley.
Bull teaches a composition comprising galantamine and amino acid such as cysteine or tryptophan. See abstract, and paragraphs 0012 and 0044-0045. The composition can be in solid dosage form such as tablet or capsule. See paragraph 0032 and 0059. The claimed amount of amino acid is found in paragraph 0012. The use of the composition to reduce substance dependency is found in the abstract; and paragraph 0009.
Bieley teaches a composition comprising combination of compounds such as 5-HTP and tryptophan for smoking cessation treatment by reducing nicotine craving. See abstract and paragraphs 0009-0020.
Thus, it would have been obvious to one of ordinary skill in the art at the time the invention was made to combine alkaloid and amino acid in a composition suitable for the treatment of substance dependency in view of the teachings in Bull and Bieley. This is because the Bull and Bieley references teach that using combination of alkaloid and amino acid for the treatment of substance abuse is known in the art.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Daskalov teaches a tablet comprising cytisine and excipients including microcrystalline cellulose.
Claims Allowable
Claims 14-16, 25 and 26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 on Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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