DETAILED ACTION
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 . 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 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.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-12) in the reply filed on 26 May 2026 is acknowledged. The traversal is on the ground(s) that the cited reference does not teach the specific formulation claimed, and that there is no search burden. This is not found persuasive because the claimed invention does not make a contribution over the art (the rationale is presented in more detail in the rejection below). And as for the search burden, this is not a requirement for restriction in view of PCT Rule 13.1. The requirement is still deemed proper and is therefore made FINAL. Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112 - Indefiniteness
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.
Claims 2-6 and 12 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claims 2-6 and 12, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 9 rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 9 recites the limitation "the amount of sodium carboxymethyl cellulose” and “the amount of mannitol”. There is insufficient antecedent basis for these limitations in the claim.
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 1-3, 8, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (PCT Patent Application Publication WO 2018/086534 – machine-generated translation provided) in view of Li et al. (US Patent Application Publication 2019/0169147).
Song et al. discloses injection preparations of vortioxetine hydrobromide which are freeze-dried powders (abstract). The preparation can comprise a suspending agent, a stabilizer, a buffering agent, a pH regulator, and a solvent (id.). The result is a preparation that has an obvious slow-release effect and can reduce times of administration, prolong the duration of the vortioxetine drug, improve patient compliance and increase bioavailability (id.).
Song et al. further states that there is not currently any long-acting injection preparations of vortioxetine or its salts, and the invention addresses this issue (page 2). However, Song et al. does not suggest including vortioxetine pamoate in the preparation, and this salt is recited by independent instant claim 1.
Li et al. discusses vortioxetine, and notes that there is a need for salts that have slower release rates and prolong the duration of vortioxetine exerting its medical effect in vivo (paragraph [4]). And the invention relates to such a salt, the pamoate salt (paragraph [5]). This vortioxetine may be administered by injection (paragraph [20]), but use of the vortioxetine preparation as a powder is not suggested.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to have included vortioxetine pamoate in the preparation disclosed by Song et al. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Instant claims 2 and 3 further limit the excipients and require a suspending agent such as sodium carboxymethyl cellulose. Such an agent is taught by Song et al. and in amounts which overlap the instantly recited amount (page 4). And in cases involving overlapping ranges, where the instantly claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. See MPEP 2144.05.
Instant claim 8 further limits the amount of the vortioxetine drug, and overlapping ranges for such amounts is taught by Song et al. (page 3).
Instant claims 10-11 recite limitations excluding ingredients, and the ingredients recited are not taught as essential by Song et al. and thus the suggested preparation reads upon these limitations.
Instant claim 12 recites a limitation to the particle size, and the particle sizes disclosed read upon the instantly recited range (example 1).
Claims 4-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (PCT Patent Application Publication WO 2018/086534) and Li et al. (US Patent Application Publication 2019/0169147) as applied to claim 1 above, and further in view of Selvaraj et al. (US Patent Application Publication 2019/0110993).
Instant claims 4-7 and 9 recite the further inclusion of a cryoprotectant such as mannitol. While Song et al. discloses freeze-dried powders, the use of a cryoprotectant is not taught therein. Selvaraj et al. discusses nanoparticle formulations, and suggests including a cryoprotectant in them. One such protectant suggested is mannitol (claim 26).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to add mannitol to the preparation disclosed by Song et al. as this would help protect the formulation during freeze-drying.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian Gulledge whose telephone number is (571) 270-5756. The examiner can normally be reached Monday - Friday 7am - 4pm.
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, Fereydoun Sajjadi can be reached at (571) 272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Brian Gulledge/Primary Examiner, Art Unit 1699
Prosecution Insights