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 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12,208,167 (‘167). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘167 patent discloses a pharmaceutical composition in the form of a tablet, said tablet comprising: a. a tablet core, wherein said core comprises benzgalantamine or salt thereof, and b. an enteric coating comprises a copolymer of methacrylic acid and ethyl acrylate, wherein said enteric coating is configured for dissolution at pH 5.5 and above, wherein the tablet core is coated by a film coating in direct contact with the tablet core and is coated by the enteric coating, and wherein the composition shows at most 10% dissolution of benzgalantamine under acidic stage at pH 1.2 at 120 minutes, and at least 80% release of benzgalantamine under a buffered stage at pH 5.5 or 6.8 after 60 minutes in the dissolution test according to USP 711. Tablet comprising filler, glidant, and lubricant is found in claims 2-7. Film coating including HPMC is found in claims 8-9. Method of treating brain disease is found in claims 23-25.
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 given the claims of the ‘167 patent. This is because the disclosed patent teaches an invention similar to that of the present claims, namely, a enteric coated tablet comprising a benzgalantamine core being directly coated with a film coating configured for dissolution at a predetermined pH.
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 9, 10, 15 and 25 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.
Claim 9 recited the limitation “wherein the tablet core is coated by a film coating” in lines 1-2. Is this coating an additional to the enteric coating recited in claim 1? If so, then the claim should be amended to clearly recite the additional limitation, for example using the language such as “further comprising”.
Claims 15 and 25 are rejected for failing to further limit the subject matter recited in claim 1. Both claims 15 and 25 recited a “film coating” that was not required in claim 1.
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 1-25 are rejected under 35 U.S.C. 103 as being unpatentable over Sacilio et al. WO 2022150917 A1, in view of Plata-Salaman US 2003/0060423 and Iksanov et al. WO 2022025785 A1.
Sacilio teaches an oral pharmaceutical composition comprising crystalline form of alpha-1062 gluconate (galantamine benzoate). See Abstract and Summary of the Invention, and pages 16-18. Pages 14-15 disclose the use of alpha-1062 gluconate for the treatment of brain disease selected from the group consisting of a brain disease with a cholinergic deficit. Oral pharmaceutical composition such as tablet comprising diluent, disintegrant, carrier and the like is found in page 22.
Sacilio does not expressly teach coating the dosage form with an enteric coating.
Plata-Salaman teaches a pharmaceutical composition comprising galantamine in an oral tablet dosage form with an enteric coating around the core. See paragraphs 0070-0073.
Plata-Salaman however does not specifically pointed out the enteric coating polymer including methacrylic acid and ethyl acrylate.
Iksanov teaches an oral tablet form comprising acetylcholinesterase inhibitor for the treatment of brain disease. The tablet dosage form is coated with an Opadry film coating, and an enteric coating comprising methacrylic acid and ethyl acrylate. See Abstract and pages 7-9. Tablet carrier includes mannitol, and colloidal silicon dioxide is found in pages 9-12.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to optimize the teaching in Sacilio with the motivation to include the galantamine benzoate in an enteric coated tablet dosage form in view of the teachings in Plata-Salaman and Iksanov with the expectation to obtain a tablet dosage form useful for oral administration of galantamine benzoate for the treatment of brain disease. This is because Sacilio suggests incorporating galantamine benzoate in an oral tablet dosage form, this is because galantamine is known as an acid labile active agent, therefore, Plata-Salaman teaches enterically coating tablet comprising galantamine is known in the art, and this is because Iksanov teaches using any known enteric copolymers and film polymer for coating acid labile active agents is known and desired in pharmaceutical art.
Claims 1-25 are rejected under 35 U.S.C. 103 as being unpatentable over Boehm et al. US 2005/0191349 A1, in view of Maelicke US 2019/0262352 A1.
Boehm teaches a galantamine formulation, wherein the formulation comprises a tablet comprising a core, a first coating and optionally a second coating. The core may include the active agent, and excipients, notably a lubricant, and a binder and/or a filler, and optionally a glidant as well as other excipients. see paragraph 0117. Examples of suitable lubricants include stearic acid, magnesium stearate, glyceryl behenate, talc, mineral oil (in PEG), etc. Examples of suitable binders include water-soluble polymer, such as modified starch, gelatin, polyvinylpyrrolidone, polyvinyl alcohol, etc. Examples of suitable fillers include lactose, microcrystalline cellulose, etc. An example of a glidant is silicon dioxide (AEROSIL, Degussa) is found in paragraph 0118. Core comprises, by dry weight, about 1 to about 25% active agent or a pharmaceutically acceptable salt thereof, about 0.5 to about 10% lubricant, and about 25 to about 98% binder or filler is found in paragraph 0119. First coating comprises a film forming polymer is found in paragraphs 0120-0121. Second coating may be designed to protect the coated tablet core from coming into contact with gastric juice, thereby preventing a food effect. The second coating may comprises an enteric polymer of the methacrylic type and optionally a plasticizer. The second coating can contain, by weight, about 40 to about 95% enteric polymer (e.g. EUDRAGIT L30D-55) and about 5 to about 60% plasticizer (e.g. triethyl citrate, polyethylene glycol). The relative proportions of ingredients, notably the ratio methacrylic polymer to plasticizer can be varied according to a methods known to those of skill in the art of pharmaceutical formulation. See paragraph 0123.
While Boehm teaches a galantamine formulation, Boehm, is deficient in the teaching of the claimed active agent, namely, benzgalantamine. However, it is quite well known in pharmaceutical art that benzgalantamine is a prodrug of galantamine. See for example the teaching in Maelicke at paragraph 0072, anti-dementive drug galantamine, the pro-drug is the benzoic ester of galantamine (galantamine benzoate, GLN 1062, otherwise mentioned as “Memogain”), and the salt forms used for intranasal delivery are preferably the lactate, gluconate, maleate or saccharate salts of said benzoylester of GLN 1062. GLN 1062 is also known as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-Benzofuro[3a,3,2-e][2]benzazepin-6-ol, 6-benzoate. For example, the gluconate salt of Memogain is also known as the galantamine benzoate gluconate.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to optimize the teaching in Boehm to, by routine experimentation include benzgalantamine in view of the teaching of Maelicke with the expectation to obtain a tablet composition useful for the delivery of benzgalantamine for the treatment of brain diseases. This is because Boehm teaches a galantamine formulation or it’s prodrug, and this is because benzgalantamine is a known prodrug of galantamine.
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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