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 .
Claims 1-14 are pending this application.
Information Disclosure Statement
Examiner notes that no Information Disclosure Statement has been filed. As a reminder, Applicants and other individuals substantially involved with the preparation and/or prosecution of the application have a duty to disclose to the office all information known to that individual to be material to patentability as defined in 37 CFR §1.56.
Claim Objections
Claims 4-14 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claims. See MPEP § 608.01(n). According to the rules the claims should not be examined on their merits. However, in order to advance prosecution, the Examiner has used his discretion to examine the claims with the expectation that in response to this office action Applicants will n\make appropriate corrections consistent with US practice.
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, 4, 6 and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shin et al. (US 2020/0281856). The reference teaches sustained-release injection containing escitalopram and method for preparing same. The claims read on the Examples 1-3 and claims 1-4.
Claims 1, 2, 4, 6 and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dancer et al. (WO2006/136169). The reference teaches crystalline escitalopram, escitalopram hydrobromide, liberation of the free base and crystallization of the base in Example 2.
“Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
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 3, 5, 7, 8, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable independently over Shin et al. (US 2020/0281856). The reference teaches sustained-release injection containing escitalopram and method for preparing same. The use of the drug is known. The claims differ by requiring a sustained release injectable pharmaceutical dosage form comprising escitalopram base which is an oil (claim 3), wherein the excipient is glycolic acid or acetic acid (claim 5), wherein the solvent is NMP or DMSO (claim 7) and wherein the administration results in steady state plasma levels of at least 20 ng/ml within five days (claim 13) and for at least 21 days (claim 14). However, selection of appropriate bases and excipients are routine to one skilled in the art. The skilled artisan would be motivated to select any base, excipient or solvent including the common one’s instant claimed and arrive at the instant claims because the skilled artisan knows of the equivalence of these.
The reference is silent on the plasma levels of escitalopram. However, this is no more than routine measurements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCK KIFLE whose telephone number is (571)272-0668. The examiner can normally be reached 8 AM - 6 PM, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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November 13, 2025
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
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