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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9 and 13-20 in the reply filed on 06/18/2026 is acknowledged.
Claims 10-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/18/2026.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-9, 13-17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al. (US Patent Pub. 20210251985).
Xu et al. disclose a lurasidone solid dispersion comprising a pharmaceutical carrier (ABSTRACT). Xu et al. disclose a formulation comprising lurasidone at 7.44%; Soluplus, which is polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer at 26.05% and HPMCAS, which is hydroxypropyl methylcellulose acetate succinate at 26.05% (TABLE 40). The composition meets the weight ratio of instant claims 2, 5, 6, 14, and 15 and the weight percentage of instant claims 3, 7 and 16. Xu et al. disclose the composition comprises excipients including surfactants, such as fatty acid glycerides ([0044] and [0045]). Xu et al. anticipate the instant claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (US Patent Pub. 2021/0251985) in view of Nandi (US Patent Pub. 2021/0236628).
Xu et al. is discussed above and differs from the instant claims insofar as they do not disclose the surfactant, polyoxylglycerides.
Nandi discloses pharmaceutical formulations, such as solid dispersions, comprising one or more surfactants, including fatty acid glycerides and polyoxylglycerides ([0012] and [0107]).
It is obvious to replace one component for another equivalent component if it is recognized in the art that two components are equivalent and is not based on the Applicant disclosure. It is also prima facie obviousness to select a known material based on its suitability for its intended use. Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function. See MPEP 2144.06. It would have been obvious to one of ordinary skill in the art to have used polyoxyglycerides in place of the surfactant in the compositions of the primary reference based on the prior art's recognition that such species are equivalent in function, as supported by cited precedent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANNETTE HOLLOMAN whose telephone number is (571)270-5231. The examiner can normally be reached Monday-Friday 9am-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NANNETTE HOLLOMAN/Primary Examiner, Art Unit 1612
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