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 statement (IDS) submitted on 4/21/25, 9/24/25, 6/5/26 were submitted in a timely fashion. The submission is 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 § 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.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Buezo et al (US 7,709,522 hereafter Buezo) in view of Singh et al (US 2019/0008806 hereafter Singh) and Parella et al (US 2020/0171025 A1 hereafter Parella).
Buezo discloses a treatment for depression with a (S)-3-fluoror-4-[4-[2-(3, 5- dimethylphenyl) pyrrolidine-1yl-methyl]phenoxy]benzamide (aticaprant) or pharmaceutically acceptable salt therefore (abstract, col. 3, lin. 25-32). The compound is present 0.5-50 mg/kg and can be administered orally (col. 12, lin. 51-67; col. 13, lin. 1-5). The formulation comprises pharmaceutical excipients (col. 8, lin. 1-20, claims).
While the reference discloses an oral formulation comprising aticaprant, the reference is silent to the specific arrangement of elements of the instant claims. The arrangement of inner and outer granular structures is well known in the art as seen in the Singh patent application.
Singh discloses as oral tablet comprising an active agent blended with excipients such as fillers, disintegrants, and glidants in an intra- and extragranular phase in a ratio above 1.5 [0058,Examples]. The filler can be microcrystalline cellulose lactose monohydrate, silicified microcrystalline cellulose and combinations thereof and present from 5-50 wt% [0051]. The disintegrant can comprise croscarmellose sodium and is present up to 10 wt % [0053]. The glidant/lubricant can be magnesium stearate or silica present from 1-10 wt% [0055-0056]. It would have been obvious to apply this structure to the compound of Buezo as it comprises similar active compounds.
While the combination of Buezo and Singh provide a tablet with an intra- and extragranular component , the combination is silent to a specific coating to the tablet. The use of film coatings applied to granulated tablets is known in the art as seen in the Parella patent application.
Parella discloses a tablet formulation comprising an active agent useful in treating depression, schizophrenia and other mental disorders where the formulation is a tablet with a film coating and an intragranular component and an extragranular components [abstract, Examples]. The tablet comprises fillers, disintegrants and lubricants/glidants [0015]. Fillers include microcrystalline cellulose, disintegrants include croscarmellose sodium and the lubricant/glidants include colloidal silica and magnesium stearate [0023-0045]. The active agent to filler ratio in the intragranular portion can be 0.8 [Example 1]. The film coating to core ratio is about 0.3 [Example 1]. It would have been obvious to include the coating of Parella onto the tablet of Buezo and Singh as it provides similar structure and components that solve the same problem.
With these aspects in mind, it would have been obvious to combine the prior art with an expected result of a stable oral tablet useful in treating depression and other mental health disorders. It would have been obvious to apply the active agent of Buezo into the biphasic tablet with an intragranular and extragranular phase as they both provide formulations that treat the same conditions. Further it would have been obvious to coat this formulation as seen in Parella patent as they also provide active agents for treating similar disorders with an intragranular and extragranular structure comprising fillers, disintegrants and lubricants/glidants and solve the same problem. One of the ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable oral formulation useful in treating mental disorders.
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 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 17-19 of U.S. Patent No. 12,201,610. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a pharmaceutical composition in the form of an oral tablet having a core comprising an intragranular and extragranular phase wherein the intragranular phase comprises aticaprant, a filler, disintegrant and a glidant and the extragranular phase comprises a filler, disintegrant and lubricant where the ratio of the intragranular to extragranular phase is from 1.5-3. The claims differ in that that 610 claims recite a specific concentration for the included aticaprant, while the instant claims remain broad. While the scope overlap, with the instant claims reciting a broader scope, the claims would act as art over one another and cannot be allowed together.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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