DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This Application is a continuation of PCT/US2023/069239 filed on 6/28/2023, which claims priority from US provisional applications 63/370,777 filed on 8/8/2022, 63/370,554 filed on 8/5/2022 and 63/357,318 filed on 6/30/2022.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 1/13/2025, is in compliance with the provisions of S7 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
The rejections are as below:
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-13 and 16-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ludwig et al. (US5427798A).
Ludwig et al. teaches a controlled sustained release tablet comprising 25 to 500 mg of bupropion hydrochloride and hydroxypropyl methylcellulose, a lubricant such as magnesium stearate is added, and for every part by weight of bupropion hydrochloride, the amount of hydroxpropyl methylcellulose is 0.19 to 1.1 and more preferably 0.267 to 0.68 parts by weight and the amount of cysteine hydrochloride. The amount of cysteine hydrochloride or glycine hydrochloride is 2.7 mg to 27 mg. particles of bupropion hydrochloride are preferably blended with microcrystalline cellulose and hydroxypropyl methylcellulose (Methocel®) to form an admixture of blended powders. Exemplified is a formulation having a core comprising the bupropion and cysteine hydrochloride.
The reference fails to specifically teach a molecular complex, or molar ratio that is from about 0.9:1 to about 1.1:1.
It would have been obvious to one of ordinary skill in the art at the time of filing to arrive at the molar ratio that is from about 0.9:1 to about 1.1:1 in a molecular complex or a combination formulation. The motivation comes from the teaching of a combination of cysteine hydrochloride and bupropion hydrochloride at 25 to 500 mg in the core of a controlled sustained release tablet. Therefore, a skilled artisan would have had reasonable expectation of successfully achieving a molecular complex of bupropion hydrochloride and cysteine hydrochloride at the molar ratio that is from about 0.9:1 to about 1.1:1.
Claims 1-13 and 16-20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Muhuri (IN2014DE00806, in applicant IDS).
Muhuri teaches a modified release formulation comprising a 50-400 mg bupropion HCl, L-cysteine hydrochloride monohydrate, ethyl cellulose, povidone, methacrylic acid copolymer, lubricants such as magnesium stearate, fillers such as microcrystalline cellulose.
The reference fails to specifically teach a molecular complex, or molar ratio that is from about 0.9:1 to about 1.1:1.
It would have been obvious to one of ordinary skill in the art at the time of filing to arrive at the molar ratio that is from about 0.9:1 to about 1.1:1 in a molecular complex or a combination formulation. The motivation comes from the teaching of a combination of cysteine hydrochloride and bupropion hydrochloride at 50-400 mg in a modified release tablet. Therefore, a skilled artisan would have had reasonable expectation of successfully achieving a molecular complex of bupropion hydrochloride and cysteine hydrochloride at the molar ratio that is from about 0.9:1 to about 1.1:1.
Claims 14-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ludwig et al. (US5427798A), as applied to claims 1-13 and 16-19 in view of Tabuteau US20190008805A1.
Ludwig et al. fails to teach the combination with dextromethorphan and bupropion.
Tabuteau teaches the combination with dextromethorphan and bupropion (abstract and claims of Tabuteau). Tabuteau provides for immediate and/or sustained release for the drugs (paragraph 237-240).
It would have been obvious to one of ordinary skill in the art at the time of filing to combine the dextromethorphan in combination with bupropion in the formulation. The motivation comes from the teaching of a combination of dextromethorphan and bupropion and the teachings of Tabuteau to arrange them in different release rates as desired. Therefore, a skilled artisan would have had reasonable expectation of successfully achieving a combination dextromethorphan and bupropion.
Claims 14-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Muhuri (IN2014DE00806), as applied to claims 1-13, 16-20 in view of Tabuteau US20190008805A1.
Muhuri et al. fails to teach the combination with dextromethorphan and bupropion.
Tabuteau teaches the combination with dextromethorphan and bupropion (abstract and claims of Tabuteau). Tabuteau provides for immediate and/or sustained release for the drugs (paragraph 237-240).
It would have been obvious to one of ordinary skill in the art at the time of filing to combine the dextromethorphan in combination with bupropion in the formulation. The motivation comes from the teaching of a combination of dextromethorphan and bupropion and the teachings of Tabuteau to arrange them in different release rates as desired. Therefore, a skilled artisan would have had reasonable expectation of successfully achieving a combination dextromethorphan and bupropion.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12156914. Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for complexes of bupropion and cysteine while also providing dosage forms that include both of these agents. Each claim set also provides for amounts and molar ratios that are similar. Each claim set also provides for a configuration of dextromethorphan as in applicant’s claims.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12678506. Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for complexes of bupropion and cysteine while also providing dosage forms that include both of these agents. Each claim set also provides for amounts and molar ratios that are similar. Each claim set also provides for a configuration of dextromethorphan as in applicant’s claims.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12357697. Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for complexes of bupropion and cysteine while also providing dosage forms that include both of these agents. Each claim set also provides for amounts and molar ratios that are similar. Each claim set also provides for a configuration of dextromethorphan as in applicant’s claims. Although the claims of ‘697 are to a method of treating depression, the claims disclose the claimed compositions within the limitations.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12661408. Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for complexes of bupropion and cysteine while also providing dosage forms that include both of these agents. Each claim set also provides for amounts and molar ratios that are similar. Each claim set also provides for a configuration of dextromethorphan as in applicant’s claims. Although the claims of ‘408 are to a method of treating depression, the claims disclose the claimed compositions within the limitations.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending application 19/270,315. Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for complexes of bupropion and cysteine while also providing dosage forms that include both of these agents. Each claim set also provides for amounts and molar ratios that are similar. Each claim set also provides for a configuration of dextromethorphan as in applicant’s claims. Although the claims of ‘315 are to a method of treating a neurological disorder, the claims disclose the claimed compositions within the limitations.
This rejection is provisional as the claims have not yet been issued as a Patent.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK V STEVENS/ Primary Examiner, Art Unit 1613
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