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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The present specification does not appear to provide adequate support for the limitation “dextromethorphan free base or a pharmaceutically acceptable salt thereof”, let alone, “dextromethorphan hydrobromide” recited in claims 22 and 26. It appears that paragraphs 0020 and 0023 are about the only two paragraphs that disclose dextromethorphan as the second active agent, and only salt of dextromethorphan such as dextromethorphan hydrochloride was mentioned.
The specification further fails to provide adequate support for the limitations “dextromethorphan free base or a pharmaceutically acceptable salt thereof is in an immediate-release formulation” and “bupropion free base or a pharmaceutically acceptable salt thereof is in an extended-release formulation”.
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.
It is noted that the Amendment filed 01/14/2026 has broaden the scope of the claims with respect to the method of treating neurological disorder in place for the “method of treating depression” as originally filed. It is known in the art that neurological disorder encompassed a wide variety of disorders such as depression, Alzheimer, ALS, seizure, schizophrenia and the like. See for example the teaching in the USPN 20140051718 A1 reference.
Further, it is noted that the preset inventor has a quite a large number of applications, and patents that are directed to the method of treating neurological disorder, including depression, Alzheimer, ALS, and the like. The following references are just to name a few that comprise combination of bupropion and dextromethorphan as sole active agents for the treatment of neurological disorder such as depression: 11,717,518; 11,839,612; 11,925,636; 11,986,444; 12,036,191; 12,042,473; 12,239,642; 12,263,161;12,364,674; 12,478,622; 12,544,345 in view of 12,357,697 B2 and 2014/0051718 A1. The claims of the 12,357,697 B2 patent disclose combination of dextromethorphan, bupropion and cysteine, wherein bupropion and cysteine are in the claimed ratio. The refences fail to teach a bilayer tablet comprising dextromethorphan and bupropion in two separate layers. However, one of ordinary skill in the art would have been motivated to, by routine experimentation preparing a dosage form that comprises bupropion and dextromethorphan in two separate layers with the expectation to: obtain a stable composition that comprises multiple active agents in a single dosage form; and deliver the active agents with sustain release, controlled release or pulsatile release profile. See for example the teaching in the claims of the 11,730,706 reference, which clearly shows a multilayer dosage form for the delivery of multiple active agents is well known and desired in the art.
Response to Arguments
Applicant's arguments filed 01/14/2026 have been fully considered but they are not persuasive.
Applicant argues that both independent claims 1 and 7 of '914, recite a dosage form comprising "about 100 mg to about 120 mg of the bupropion in the free base form or a salt form," which is distinct from the "about 91 mg of the bupropion free base or salt" claimed in '473 patent. The Examiner has not established why one of ordinary skill in the art would have been motivated to modify the combination of the claims of '473 and '914 to arrive at the 90-120 mg of bupropion dosage in a bilayer formulation as claimed. Moreover, the claims of '473 patent relate to a method for treating depression, and the claims of '914 patent relate to a dosage form. The combination of the claims of '473 and '914 does not arrive at the claimed method of treating neurological disorder.
However, Applicant’s arguments are not persuasive for the following reasons:
First, in response to Applicant’s argument that the claims of the ‘473 patent relate to a method of treating depression, not a method of treating neurological disorders as required in the present claims, it is noted that the limitation “neurological disorders” required in the preset claims is broader and it includes any neurological disorder, namely, depression. See claims 41 and 42 of USPN 20140051718. Note: this is not a new rejection. USPN 20140051718 is cited to show what’s known in the art;
Second, in response to Applicant’s argument that both independent claims 1 and 7 of '914, recite a dosage form comprising "about 100 mg to about 120 mg of the bupropion in the free base form or a salt form," which is distinct from the "about 91 mg of the bupropion free base or salt" claimed in '473 patent, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here, the ‘914 patent is cited solely for the teaching of the bilayer tablet that comprises the active agents in two separate layers; and
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the ‘473 patent discloses a method of treating depression in a human patient comprising administering a combination dextromethorphan in the free base form at a dose of about 33 mg twice daily, or a molar equivalent amount of a salt form of dextromethorphan, and the second agent is bupropion in the free base form at a dose of 91 mg twice daily, or a molar equivalent amount of a salt form of bupropion, wherein the combination of the dextromethorphan and the bupropion are administered in a dosage form that further comprises an L-cysteine. See Claims 1, 4 and 7. The ‘473 is only deficient in the teaching of a dosage form, which is a bilayer dosage form. However, bilayer dosage form comprising combination of bupropion, dextromethorphan and cysteine is known in the art. See for example the teaching in the ‘914 patent. As such, one of ordinary skill in the art would have been motivated to, by routine experimentation preparing a dosage form that comprises bupropion and dextromethorphan in two separate layers with the expectation to: obtain a stable composition that comprises multiple active agents in a single dosage form; and deliver the active agents with sustain release, controlled release or pulsatile release profile. The ‘914 patent clearly shows a multilayer dosage form for the delivery of multiple active agents is well known and desired in the art.
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 1-6 and 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ruff et al. US 5,358,970, in view of Huang et al. US 9,364,458 and Bear US 20200197388 A1.
Claims 7, 8 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ruff et al. US 5,358,970, in view of Huang et al. US 9,364,458 and Bear et al. US 20200197388 and Tabuteau US 20160128998 A1.
These rejections have been withdrawn in view of the Amendment filed 01/14/2026.
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