DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 15-17 and 24 are withdrawn.
Claims 1, 5, 8-10, and 23 are pending and represent all claims currently under consideration.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/28/2026 has been entered.
Election/Restrictions
Claims 15-17 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 02/18/2025.
The new claim 24 is directed to the non-elected Group II.
Priority
This application is a 371 of PCT/US2020/070788.
Claims 1, 5, 8-10, and 23 are considered to have an effective filing date of 11/15/2019.
Response to Arguments
Applicant’s arguments, see Remarks (pages 6-7), filed 05/28/2026, with respect to the rejection(s) of claim(s) 1, 5-10, and 22 under 35 U.S.C. 103 have been fully considered and are persuasive due to the amendment. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yoon (WO 2018075481 A1; IDS reference, 03/31/2023), further in view of Han (Pharmaceutics, 2018).
New 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.
Claims 1, 5, 8-10, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon (WO 2018075481 A1; IDS reference, 03/31/2023), further in view of Han (Pharmaceutics, 2018). Yoon was cited previously by the Examiner.
Regarding claim 1, Yoon teaches a pharmaceutical composition comprising an NMDA receptor antagonist (Yoon, claim 20) which can be in the form of microparticles (Yoon, page 26, line 10), comprising a pharmaceutically acceptable carrier (Yoon, page 14, line 9) which can be a diluent or excipient and an encapsulating material (i.e., for encapsulating the NMDA receptor agonist; Yoon, page 7, lines 20-23). Yoon further teaches the NMDA receptor agonist can be administered in a dose of 100-200 mg (Yoon, page 15, line 30-31). Yoon teaches the NMDA receptor antagonist is selected from the group comprising ketamine, R-ketamine, and S-ketamine (Yoon, claim 11). Yoon teaches an average particle size of from about 0.2-500 micrometers (Yoon, page 25, line 16), which encompasses the claimed range of 20-60 micrometers. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Yoon teaches the dose as stated above, but does not specify a loading % by weight, and Yoon teaches the formulation can comprise a biodegradable polymer system (Yoon, page 23, line 32), but does not specify the polymer type. Han, however, teaches biodegradable microparticles comprising ketamine (i.e., an NMDA antagonist from the claimed list “ii”) encapsulated in PLGA (i.e., a biodegradable polymer from the claimed list “i”) with a size of 20-45 micrometers, which lies within the claimed range, and a drug loading of 10% (Han, abstract), which lies within the claimed range. Han teaches an example using PLGA 75:25 (i.e., a ratio of PLA to PGA of about 75:25 as claimed; Han, table 1, polymer 4). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Yoon further teaches formulations may be for sustained release (Yoon, page 25, lines 33-34), but does not specify a time frame of release. Han, however, teaches a sustained-release profile of greater than or equal to 21 days (Han, page 11, conclusions), which encompasses the claimed range.
Yoon and Han are considered to be analogous to the claimed invention, because both are in the same field of pharmaceutical microparticle compositions comprising ketamine. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Yoon to have included the specific biodegradable polymer and loading amount taught by Han to arrive at the claimed invention, because Yoon teaches an appropriate effective amount in any individual case may be determined by one of ordinary skill in the art using routine experimentation (Yoon, page 8, lines 25-27), while Han teaches microparticles having the claimed biodegradable polymer and sustained release, without a need for surfactants and toxic solvents (Han, page 11, conclusions). It would also be reasonable to expect the same biodegradable polymer would result in the claimed release profile.
Regarding claim 5, Yoon and Han together teach all the elements of the current invention as applied to claim 1. As above, Yoon teaches the formulation can comprise a biodegradable polymer system (Yoon, page 23, line 32), but does not specify the polymer type. Han teaches an ester end-capped PLGA results in the best sustained-release profile (Han, abstract). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Yoon to have included the specific biodegradable polymer taught by Han to arrive at the claimed invention, because Han teaches the end-capped polymers results in a reduced rate of ketamine release (Han, page 8, 1st paragraph).
Regarding claim 8, Yoon and Han together teach all the elements of the current invention as applied to claim 1. Yoon teaches a pharmaceutical composition (Yoon, claim 20) comprising a pharmaceutically acceptable carrier (Yoon, page 14, line 9) and excipients which can be ethyl cellulose (Yoon, page 7, lines 30-31), hydroxypropyl cellulose, or hydroxypropylmethylcellulose (Yoon, page 22, lines 14-15).
Regarding claim 9, Yoon and Han together teach all the elements of the current invention as applied to claim 1. Yoon teaches a pharmaceutical composition (Yoon, claim 20) comprising a pharmaceutically acceptable carrier (Yoon, page 14, line 9) which can be an excipient (Yoon, page 7, lines 20-22) and can include sugars, starches, gelatin, and polyethylene glycol (Yoon, page 7, line 29 – page 8, line 1).
Regarding claim 10, Yoon and Han together teach all the elements of the current invention as applied to claim 1. Yoon teaches a pharmaceutical composition (Yoon, claim 20) comprising a pharmaceutically acceptable excipient such as binding agents (i.e., binders), coatings, disintegrants, fillers, and lubricants (Yoon, page 22, lines 13-16).
Regarding claim 23, Yoon and Han together teach all the elements of the current invention as applied to claim 1. As above, Yoon teaches formulations may be for sustained release (Yoon, page 25, lines 33-34), but does not specify a time frame of release. Han, however, teaches a sustained-release profile of greater than or equal to 21 days (Han, page 11, conclusions), which encompasses the claimed range.
Conclusion
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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