DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/03/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-9 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.
Regarding claims 1-3 and 8-9, the phrase "e.g.," renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 1-6 and 8-9 recite the terms “amisulpride derivative/amisulpride derivative disclosed herein” which is unclear because it is unclear what is encompassed by “derivative.” Furthermore, incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). See MPEP 2173.05(s).
Applicant may overcome this rejection by deleting exemplary language and reciting specific amisulpride derivatives within the claim(s).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US20180155282A1.
US20180155282A1 discloses methods for delivering a dopamine and/or serotonin (e.g., 5-HT2a) and/or alpha-2 adrenergic (α2) receptor antagonist to the brain of a subject comprising administering to the subject an amisulpride derivative; for antagonizing dopamine and/or serotonin (e.g., 5-HT2a) and/or α2 receptor in a subject comprising administering to a subject the amisulpride derivatives therein; and methods for treating one or more conditions responsive to modulation of dopamine and/or serotonin (e.g., 5-HT2a) and/or α2 receptor in a subject comprising administering to a subject the amisulpride derivatives disclosed therein. (Para. [0008] – [0012]). The compound LB-102 is taught as an amisulpride derivative (Para. [0016], Para. [0087], Examples 1-9). Examples 4-7 show binding to dopamine receptors and Examples 8-9 show efficacy in in vivo assays. Single or multiple doses of the compounds are contemplated … In some embodiments, the compound is administered once a day (Para. [0078]). Said unit dosage applied to the preferred compound of LB-102 would be at once envisaged by a PHOSITA. Accordingly, claims 1-6 are anticipated.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over US20180155282A1.
US20180155282A1 discloses methods for delivering a dopamine and/or serotonin (e.g., 5-HT2a) and/or alpha-2 adrenergic (α2) receptor antagonist to the brain of a subject comprising administering to the subject an amisulpride derivative; for antagonizing dopamine and/or serotonin (e.g., 5-HT2a) and/or α2 receptor in a subject comprising administering to a subject the amisulpride derivatives therein; and methods for treating one or more conditions responsive to modulation of dopamine and/or serotonin (e.g., 5-HT2a) and/or α2 receptor in a subject comprising administering to a subject the amisulpride derivatives disclosed therein. (Para. [0008] – [0012]). The compound LB-102 is taught as an amisulpride derivative (Para. [0016], Para. [0087], Examples 1-9). Examples 4-7 show binding to dopamine receptors and Examples 8-9 show efficacy in in vivo assays. The actual dosage amount of the compound administered to a subject may be determined by physical and physiological factors such as age, sex, body weight, severity of condition, the type of disease being treated, previous or concurrent therapeutic interventions, idiopathy of the subject and on the route of administration. These factors may be determined by a skilled artisan. The practitioner responsible for administration will typically determine the concentration of active ingredient(s) in a composition and appropriate dose(s) for the individual subject. In one embodiment, a human subject is administered the daily doses of from about 0.01 mg/kg to about 100 mg/kg. Single or multiple doses of the compounds are contemplated. Desired time intervals for delivery of multiple doses can be determined by one of ordinary skill in the art employing no more than routine experimentation … In some embodiments, the compound is administered once a day (Para. [0076] - [0078]).
US20180155282A1 does not teach wherein the unit dose is 50 mg, 75 mg, or 100 mg.
US20180155282A1 teaches general working conditions for dosing parameters and a range of 0.01mg/kg to about 100 mg/kg for human administration. With respect to claim 8, to arrive at a dosage of 50 mg, 75 mg, or 100 mg amounts to routine optimization. See MPEP 2144.05(II).
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over US20180155282A1 in view of Kapur.
US20180155282A1 discloses methods for delivering a dopamine and/or serotonin (e.g., 5-HT2a) and/or alpha-2 adrenergic (α2) receptor antagonist to the brain of a subject comprising administering to the subject an amisulpride derivative; for antagonizing dopamine and/or serotonin (e.g., 5-HT2a) and/or α2 receptor in a subject comprising administering to a subject the amisulpride derivatives therein; and methods for treating one or more conditions responsive to modulation of dopamine and/or serotonin (e.g., 5-HT2a) and/or α2 receptor in a subject comprising administering to a subject the amisulpride derivatives disclosed therein. (Para. [0008] – [0012]). The compound LB-102 is taught as an amisulpride derivative (Para. [0016], Para. [0087], Examples 1-9). Examples 4-7 show binding to dopamine receptors and Examples 8-9 show efficacy in in vivo assays. The actual dosage amount of the compound administered to a subject may be determined by physical and physiological factors such as age, sex, body weight, severity of condition, the type of disease being treated, previous or concurrent therapeutic interventions, idiopathy of the subject and on the route of administration. These factors may be determined by a skilled artisan. The practitioner responsible for administration will typically determine the concentration of active ingredient(s) in a composition and appropriate dose(s) for the individual subject. In one embodiment, a human subject is administered the daily doses of from about 0.01 mg/kg to about 100 mg/kg. Single or multiple doses of the compounds are contemplated. Desired time intervals for delivery of multiple doses can be determined by one of ordinary skill in the art employing no more than routine experimentation … In some embodiments, the compound is administered once a day (Para. [0076] - [0078]).
US20180155282A1 does not teach measuring dopamine RO% and modulating the unit dose to achieve a desired range.
Applicant-admitted prior art at Para. [0025] establishes that “Dopamine receptor occupancy (RO) is a well-established marker of antipsychotic efficacy: 60 to 75% RO correlates to meaningful improvements in PANSS scores in schizophrenia patients. Kapur teaches “(i) the `typical' antipsychotics bind mainly to the dopamine D2 receptor, and that 60±80% D2 occupancy may provide optimal antipsychotic response with little extrapyramidal side effects;” (Abstract) and “It has been known for almost two decades that antipsychotic effects and extrapyramidal side effects (as well as catalepsy in animals) are related to the dopamine D2 blocking properties of antipsychotics … These data suggest that there may be a therapeutic window, perhaps between 60% and 80% D2 occupancy, which may yield adequate antipsychotic response with low or minimal EPS.” It is well-known in the art that dopamine RO% is predictive of patient outcomes in treatment with antipsychotics. Accordingly, it would have been obvious to a PHOSITA apply the teachings of Kapur to measure and adjust the dosage of an amisulpride derivative such as LB-102 taught by Vaino et al. in order to achieve an optimal dopamine RO%. Accordingly, claims 1-9 are obvious.
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 1-3 and 5-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10259786. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims are drawn to amisulpride derivatives equivalent to those “disclosed herein” (see instant Para. [0045] – [0047]) and their methods of administration. Administration of said amisulpride derivatives anticipates claims 1-2 as delivery to the brain and/or antagonism of dopamine and/or serotonin and/or a2 receptor necessarily occurs upon administration. Furthermore, issued claims 7 and 9 anticipate claim 3 as they are drawn to disease treatment. Claims 5-7 amount to routine optimization and claims 8-9 are obvious for reasons as discussed in the obviousness rejection which apply in equal or greater force.
Claims 1-3 and 5-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10167256. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims are drawn to amisulpride derivatives equivalent to those “disclosed herein” (see instant Para. [0045] – [0047]) and their methods of administration. Administration of said amisulpride derivatives anticipates claims 1-2 as delivery to the brain and/or antagonism of dopamine and/or serotonin and/or a2 receptor necessarily occurs upon administration. Furthermore, issued claim 9 anticipates claim 3 as it is drawn to disease treatment. Claims 5-7 amount to routine optimization and claims 8-9 are obvious for reasons as discussed in the obviousness rejection which apply in equal or greater force.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11040943. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims are drawn to amisulpride derivatives equivalent to those “disclosed herein” (see instant Para. [0045] – [0047]) and their methods of administration. Compounds of Formula 1A wherein one of X is H and the other is CH3 (see at least issued claims 6 and 8) are equivalent to LB-102 of instant claim 4. Administration of said amisulpride derivatives anticipates claims 1-2 as delivery to the brain and/or antagonism of dopamine and/or serotonin and/or a2 receptor necessarily occurs upon administration. Furthermore, issued claim 12 anticipates claim 3 as it is drawn to disease treatment. Claims 5-7 amount to routine optimization and claims 8-9 are obvious for reasons as discussed in the obviousness rejection which apply in equal or greater force.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10689338. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims are drawn to amisulpride derivatives equivalent to those “disclosed herein” (see instant Para. [0045] – [0047]) and their methods of administration. Issued claim 1 is drawn to LB-102 of instant claim 4. Administration of said amisulpride derivatives anticipates claims 1-2 as delivery to the brain and/or antagonism of dopamine and/or serotonin and/or a2 receptor necessarily occurs upon administration. Furthermore, issued claims 5-9 anticipate claim 3 as they are drawn to disease treatment. Claims 5-7 amount to routine optimization and claims 8-9 are obvious for reasons as discussed in the obviousness rejection which apply in equal or greater force.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11377421. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims are drawn to amisulpride derivatives equivalent to those “disclosed herein” (see instant Para. [0045] – [0047]) and their methods of administration. Issued claim 1 is drawn to LB-102 of instant claim 4. Administration of said amisulpride derivatives anticipates claims 1-2 as delivery to the brain and/or antagonism of dopamine and/or serotonin and/or a2 receptor necessarily occurs upon administration. Furthermore, issued claims 5-9 anticipate claim 3 as they are drawn to disease treatment. Claims 5-7 amount to routine optimization and claims 8-9 are obvious for reasons as discussed in the obviousness rejection which apply in equal or greater force.
Claims 1-3 and 5-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11713295. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims are drawn to amisulpride derivatives equivalent to those “disclosed herein” (see instant Para. [0045] – [0047]) and their methods of administration. Administration of said amisulpride derivatives anticipates claims 1-2 as delivery to the brain and/or antagonism of dopamine and/or serotonin and/or a2 receptor necessarily occurs upon administration. Claims 5-7 amount to routine optimization and claims 8-9 are obvious for reasons as discussed in the obviousness rejection which apply in equal or greater force.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12060327. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims are drawn to amisulpride derivatives equivalent to those “disclosed herein” (see instant Para. [0045] – [0047]) and their methods of administration. At least issued claim 1 is drawn to LB-102 of instant claim 4. Administration of said amisulpride derivatives anticipates claims 1-2 as delivery to the brain and/or antagonism of dopamine and/or serotonin and/or a2 receptor necessarily occurs upon administration. Furthermore, issued claims 2-13 anticipate claim 3 as they are drawn to disease treatment. Claims 5-7 amount to routine optimization and claims 8-9 are obvious for reasons as discussed in the obviousness rejection which apply in equal or greater force.
Claims 1-9 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 19534590 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to amisulpride derivatives equivalent to those “disclosed herein” (see instant Para. [0045] – [0047]) and their methods of administration. At least copending claims 6 and 8 are drawn to LB-102 of instant claim 4. Administration of said amisulpride derivatives anticipates claims 1-2 as delivery to the brain and/or antagonism of dopamine and/or serotonin and/or a2 receptor necessarily occurs upon administration. Furthermore, copending claims 13-26 anticipate claim 3 as they are drawn to disease treatment. Claims 5-7 amount to routine optimization and claims 8-9 are obvious for reasons as discussed in the obviousness rejection which apply in equal or greater force.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 19574114 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to amisulpride derivatives equivalent to those “disclosed herein” (see instant Para. [0045] – [0047]) and their methods of administration. At least copending claim 2 is drawn to LB-102 of instant claim 4. Administration of said amisulpride derivatives anticipates claims 1-2 as delivery to the brain and/or antagonism of dopamine and/or serotonin and/or a2 receptor necessarily occurs upon administration. Furthermore, copending claims 1-6 anticipate claim 3 as they are drawn to disease treatment. Claims 5-7 amount to routine optimization and claims 8-9 are obvious for reasons as discussed in the obviousness rejection which apply in equal or greater force.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-9 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JED A KUCHARCZK/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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