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 . Claims included in prosecution are claims 1, 4 and 9-13.
Previous Rejections
Applicants' arguments in the Request for Continued Examination, filed Apr. 24, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 103 (New)
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.
1. Claims 1, 4, and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kandula (WO 2019/186357, Oct. 3, 2019) (hereinafter Kandula) in view of Fava et al. (US 2017/0042878, Feb. 16, 2017) (hereinafter Fava).
Kandula teaches pharmaceutical compositions comprising compounds of formula I or intermediates thereof and one or more of pharmaceutically acceptable excipients and/or pharmaceutically acceptable carriers, wherein formula I represents ketamine and RH comprises acids such as pamoic acid (¶ [0008]).
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In the compound of formula I, the ketamine moiety can exist as R enantiomer, S enantiomer or a mixture thereof in equal proportions and one of the enantiomer could be selected for the salt preparation process (satisfies active of claim 1) (¶ [0010]). The pharmaceutical composition comprising the compound of formula I is formulated as a dosage form such as intramuscular and sustained release (satisfies forms of claim 1 & 12) (¶ [0018]). Suitable pharmaceutically acceptable excipients include wetting agents and buffering agents (satisfies claim 9) (¶ [0030]). Suitable pharmaceutically acceptable carriers include sodium carboxymethyl cellulose and polyethylene glycol (satisfies carrier of claim 1) (¶ [0031]). The composition may utilize nanoparticles in drug delivery (¶ [0055]). The pharmaceutical compositions can be formulated by combining the compositions and the pharmaceutically acceptable excipient and/or carriers in the form of injectable solutions (¶ [0056]). The active ingredient can be presented in the pharmaceutical compositions for parenteral use in a concentration of from about 0.05 to about 50% w/v (satisfies claim 10-11) (¶ [0062]).
Kandula differs from the instant claims insofar as not disclosing wherein the formulation is in the form of injectable aqueous suspension.
However, Fava discloses compositions and methods for administering scopolamine and ketamine (Abstract). In an embodiment, ketamine or scopolamine are injected into the blood stream, a body cavity or a subcutaneous tissue of the human subject (¶ [0019]). Aqueous suspensions can contain an active agent such as ketamine for the manufacture of aqueous suspensions, e.g., for aqueous intradermal injections (¶ [0061]).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of instant application to have formulated the composition of Kandula to be in the form of an injectable aqueous suspension since this is a known an effective administration route for ketamine as taught by Fava.
Regarding claim 1 reciting a composition comprising a crystal form of the active, Kandula discloses the use compounds or its pharmaceutical acceptable polymorphs, solvates, enantiomers, stereoisomers and hydrates thereof (Abstract). The term "polymorph" refers to one crystal structure of a given compound (¶ [0026]). Accordingly, the compound of Kandula may be in the crystal form and satisfies the instantly recited limitation.
Regarding claim 1 reciting a stoichiometry of 2:1 between the ketamine and pamoate, pamoic acid contains two carboxyl groups. Accordingly, one of ordinary skill in the art would reasonably conclude that each carboxyl group can form a carboxylate salt with ketamine, which would result in two ketamines for each pamoic acid, i.e., a 2 to 1 ratio of ketamine to pamoate or a stoichiometry of 2:1.
Regarding the particle size recited in instant claim 4 (i.e., (d50) of less than 20 microns), as discussed above, Kandula discloses wherein the composition may utilize nanoparticles in its drug delivery mechanism. As such, since Kandula discloses the use of nanoparticles and nanoparticles have a particle size of less than 100 nm (i.e., 0.1 micron), it would reasonable for one of ordinary skill in the art to conclude that Kandula’s particles would have average particle sizes that encompass the d(50) values recited in the instant claim.
Regarding the specific surface area recited in instant claim 4 (i.e., 300 m2/g) and resistance to heat recited in instant claim 13, specific surface area and heat resistance are descriptive and thus would be properties of the claimed product. Kandula discloses substantially the same composition comprising substantially the same actives, pharmaceutically acceptable carriers, and pharmaceutically acceptable excipients. Kandula further discloses a particle size encompassed by the instant claims and substantially the same administration methods. Therefore, it would reasonable for one of ordinary skill in the art to conclude that the particles/product of Kandula would have substantially the same specific surface area and heat resistance as the particle/product of the instant claims.
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.
1. Claims 1, 4, and 9-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,981,617 B2 (hereinafter ‘617).
Although the claims at issue are not identical, they are not patentably distinct from each other because they both disclose a ketamine pamoate salt having a stoichiometry of 2:1 of ketamine to pamoate and a pharmaceutical composition comprising the same. The difference between the instant claims and the ‘617 claims lies in the fact that the instant claims recite a “sustained release pharmaceutical composition” comprising the compound of the patented claims. As such, it would have been obvious for one of ordinary skill in the art to have used the ketamine pamoate salt of ‘671 in the sustained release pharmaceutical composition of the instant claim since it is the same active recited in the instant claims.
Response to Arguments
Applicant’s arguments with respect to claims 1, 4, and 9-13 have been considered but are moot because new rejections necessitated by Applicant’s amendment have been made. As discussed in the current rejections Kandula discloses a pharmaceutical composition comprising a compound of Formula I (i.e., ketamine) as an active ingredient in a therapeutically effective amount and a pharmaceutically acceptable carrier, wherein the RH in Formula I is pamoic acid (namely, the compound is ketamine pamoate salt), the ketamine moiety in Formula I is selected from an R enantiomer, an S enantiomer, or a racemic mixture comprising equal portions of R and S enantiomers of ketamine. Fava’s teaching in reference to aqueous ketamine suspensions for injection is applied to meet the requirements of the new limitation “wherein the sustained-release pharmaceutical composition is an injectable aqueous suspension”.
Conclusion
Claims 1, 4, and 9-13 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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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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/A.A./Examiner, Art Unit 1612
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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