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 1, 5-10, and 22 are pending and represent all claims currently under consideration.
Response to Amendment
The amendment filed 09/05/2025 has been entered.
Claims 3-4 were canceled. Claims 1, 5-6, and 8-9 were amended. Claim 22 was added. No new material was added.
Applicant’s amendments have overcome the previous rejections under 35 U.S.C. 112(b) and objections to the claims and specification.
The rejections of claims 3-4 are moot, because the claims were canceled.
The rejections of claims 1 and 5-10 under 35 U.S.C. 103 have been modified to address the amendments and maintained.
Claim 22 is newly rejected under 35 U.S.C. 103.
Priority
This application is a 371 of PCT/US2020/070788.
Claims 1, 5-10, and 22 are considered to have an effective filing date of 11/15/2019.
Response to Arguments
Applicant's arguments filed 09/05/2025 have been fully considered but they are not persuasive.
Applicant argues that Yoon merely mentions that the NMDA receptor agonist may be in the form of microparticles with no description of the polymers or details of microparticles and states that Yoon never fully describes or enables a composition comprising an NMDA antagonist encapsulated in microparticles. Applicant further states that undue experimentation would be required to create the claimed composition (Remarks, pages 7-8). This argument is not persuasive, because as stated below, Yoon and King together teach all the elements of the amended claim 1. Specifically, Yoon teaches a pharmaceutical composition comprising an NMDA receptor agonist (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). It is well established that a reference is presumed to have an enabling disclosure barring evidence to the contrary (see MPEP § 2121). It is the burden of the applicant to submit evidence showing that the disclosure of Yoon is not enabling for an NMDA antagonist encapsulated in microparticles. Applicant arguments are more than allegations that find support neither in technical reasoning nor in evidence of record. The examiner further points to MPEP § 2121.01 (II): “Even if a reference discloses an inoperative device, it is prior art for all that it teaches.” Clearly, Yoon teaches a composition comprising an NMDA antagonist encapsulated in microparticles as claimed.
Applicant argues that the particle size mentioned in Yoon (Yoon, page 25, line 16) is directed to an intranasal formulation of coarse powder and not related to microparticles (Remarks, page 8, 3rd paragraph). This argument is not persuasive, because Yoon teaches the compounds may be administered in the form of microparticles (Yoon, page 26, lines 9-10) and teaches a formulation suitable for administration as a coarse particle having an average particle size of about 0.2 to 500 micrometers (Yoon, page 25, lines 15-17). One of ordinary skill in the art would reasonably accept that a coarse particle of micrometer size would be a “microparticle” as claimed.
Applicant argues that King does not teach an NMDA antagonist from the list of the amended claim and that compositions comprising microparticles are specific for different therapeutic agents. Applicant states that King does not teach, suggest, or motivate one skilled in the art to design the instantly claimed invention for a NMDA receptor agonist encapsulated by microparticles (Remarks, page 8, 4th paragraph). This argument is not persuasive, because both Yoon and King teach a pharmaceutical composition comprising an NMDA antagonist as discussed below and King further teaches an embodiment in which microspheres (i.e., microparticles) are loaded with the therapeutic agent (King, page 8, paragraph 0075). As previously stated, Yoon teaches an NMDA antagonist from the list of the amended claim 1. King is a secondary reference, utilized to expand on the use of a biodegradable polymer system as taught by Yoon. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references.
Modified/Maintained 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 and 5-10 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 King (US 20090263459 A1; IDS reference, 03/31/2023). The references were 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 the formulation can comprise a biodegradable polymer system (Yoon, page 23, line 32), but does not specify the polymer type. King teaches a therapeutic composition (King, abstract) comprising a therapeutic agent which can be an NMDA antagonist (King, page 5, paragraph 0046) and which can be a biodegradable microparticle (King, page 6, paragraph 0065). King further teaches the composition comprising PLGA or PLA (i.e., biodegradable polymers; King, page 4, paragraph 0042).
Yoon and King are considered to be analogous to the claimed invention, because both are in the same field of pharmaceutical microparticle compositions comprising NMDA antagonist. 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 King to arrive at the claimed invention, because King teaches the polymer type affects the conditions for (King, page 6, paragraph 0054) and duration of drug delivery (King, page 6, paragraph 0058).
Regarding claim 5, Yoon and King 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. King, however, teaches the composition comprising PLGA (King, page 4, paragraph 0042) and further teaches the PLGA can have ester end groups (i.e., capped; King, page 6, paragraph 0058). 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 King to arrive at the claimed invention, because King teaches the polymer end groups can result in a lower burst index and regulated duration of delivery (King, page 6, paragraph 0058).
Regarding claim 6, Yoon and King 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. King, however, teaches the composition comprising 85/15 or 75/25 PLGA (i.e., a ratio of PLA to PGA of 85:15 or 75:25; King, page 6, paragraph 0058). As above, 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 King to arrive at the claimed invention, because King teaches the polymer type affects the conditions for (King, page 6, paragraph 0054) and duration of drug delivery (King, page 6, paragraph 0058).
Regarding claim 7, Yoon and King together teach all the elements of the current invention as applied to claim 1. 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).
Regarding claim 8, Yoon and King 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 King 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 King 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).
New Claim Rejections - 35 USC § 103
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Yoon (WO 2018075481 A1; IDS reference, 03/31/2023), further in view of King (US 20090263459 A1; IDS reference, 03/31/2023), as applied to claims 1 and 5-10. The references were cited previously by the Examiner.
Regarding claim 22, Yoon teaches all the elements of the current invention as applied to claim 1. As above, Yoon teaches the pharmaceutical composition comprising an NMDA receptor antagonist (Yoon, claim 20) which can be in the form of microparticles (Yoon, page 26, line 10). Yoon further teaches the NMDA receptor antagonist is present in a therapeutically effective amount (Yoon, abstract), but does not specify what weight percentage a therapeutically effective amount corresponds to. King, however, teaches microspheres loaded with a therapeutic agent as a drug depot (King, page 8, paragraph 0075) and teaches a drug depot having a loading of the therapeutic agent of 20-30% by weight (King, page 6, paragraph 0055), which lies within the claimed range. As stated above, King teaches a therapeutic agent which can be an NMDA antagonist (King, page 5, paragraph 0046). 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 an antagonist loading amount as taught by King, 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 King teaches an exemplary amount.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613