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 .
A request for Prioritized Examination (Track 1) on this Application was granted on 03/05/25. Accordingly, this Application is examined under Special status.
Receipt is acknowledged of Amendments, Remarks, a Declaration and an IDS filed on 09/22/25. Claims 32, 34-35, 37-38, 40-41, 44-49, 51-52, 54-55 have been amended, new claims 58-65 have been added and no claims have been canceled. Accordingly, claims 32-65 are pending and under examination on the merits.
Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 47-57, 59-61 and 63-65 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 47 includes the limitation of “about 30-79.8% by weight of a carbohydrate bulking agent”. The Specification does not provide support for this limitation. The Specification recites a range of 30-95% carbohydrate, a range of 30 to 80% (See [0064] and [0066] of the published version) and an example where lactose monohydrate is present at 79.2% (See Example 6). However, there is no support for the range of 30 to 79.8% and there is no support for single point 79.8%.
Claims 64 and 65 include the recitation of “each sequence of administration takes place in a period of about 15 minutes”. The Specification states that “Preferably, such as sequence lasts at least 30 minutes, for example lasts 30 minutes, and includes 3 sequences of administration and break periods between are preferably equal, i.e. are 15 minutes break (rest) period” (See [0049]). The Specification fails to provide support for each sequence administration taking place in about 15 minutes.
Claims 48-57, 59-61 and 63 are rejected for depending on and containing the new matter of claim 47.
These rejections are new matter rejections.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 32-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,925,607 as evidenced by Singh et al (US 20160338977). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the reference claims as evidenced by Singh et al.
Instant claim 32 is directed to a method of treating bipolar depression comprising administering to a patient in need thereof a dosage form comprising a dry powder composition formulated for administration to the lungs via oral inhalation, wherein the dry powder composition comprises: a nominal unit dose of esketamine, or a pharmaceutically acceptable salt thereof, and wherein the nominal unit dose is 4 mg, calculated as free base; 30 - 95% by weight of a carbohydrate bulking agent; and 0.2 - 3% by weight of a stabilizing agent. Instant claims 41-42, 46, 55-56 and 57 add the administration of multiple sequences and a break period being 15 minutes.
Reference claim 1 is directed to a method of treating depression in a subject comprising administration to the lungs of the subject via pulmonary route of an inhalable pharmaceutical composition comprising ketamine or its isomer or its pharmaceutically acceptable salt, wherein said treating is performed in a dosage regimen that comprises a 10 days to a 30 days cycle of multiple administrations by inhalation, wherein each administration of the multiple administrations is performed on a single day with an interval of 2 to 4 days between each administration, wherein each administration of the multiple administrations consists of a sequence of multiple single dose inhalations, and wherein each single dose inhalation in said sequence is separated by a break period lasting about 15 minutes. Reference claim 8 discloses the concentration ranges of the bulking agent and stabilizing agent. Reference claim 9 recites the particle diameter, and claim 10 recites fraction of emitted dose. The method of reference claim 18 recites the sequences of administration and wherein the esketamine hydrochloride is present in an amount of 2 mg to 20 mg calculated as free base.
The differences between the recited claims of the instant application and the reference claims include reference claims stating depression while examined claims recite bipolar depression. This is however, obvious as evidenced by Singh et al and the reference patent. Singh et al disclose that depression includes bipolar depression. Reference Patent also states in the background section, that depression, especially major depressive disorder, bipolar disorder, … Thus, it is clear that reference claim’s depression encompasses instant claim’s bipolar depression. The other difference is the arrangement of the limitations between the two claim sets. For example, examined claim 32 includes the concentration ranges, which are recited in claim 8 of the reference claims. The sequence of applications in reference claim 1 is recited in depending claims 41-42, 4, 55-57 of the examined claims. Examined claims 34-35, 48-49 recite the particle size distribution which are present in reference claim 9. Examined claims 40 and 54 recite the fraction of the emitted dose being from 40 to 85%, which is included in reference claims 11 and 17.
The said differences however, are obvious and the claims are not mutually exclusive since the claims are drawn to the same method, same dry powder composition comprising esketamine or esketamine hydrochloride, same bulking agent, same stabilizing/force control agent, and same specifics of the composition and delivery.
That is, the recited claims of the instant application and the reference claims are not mutually exclusive or patentably distinguishable.
Response to Arguments and Declaration
Applicant’s arguments and Declaration filed 09/22/25, with respect to rejection of claims under obviousness over the references of record have been fully considered and are persuasive. The rejection of claims 32-57 under USC 103 over Charney et al in view of Staniforth et al, Jonkman et al and Singh et al has been withdrawn.
Regarding the rejection of claims 32-57 under obviousness type double patenting over the reference patent No. 11,925,607 as evidenced by Sing et al is not persuasive and the rejection is maintained. Applicant’s argument is that claims as amended are not unpatentable over claims 1-20 of the ‘607 patent (See Remarks, page 25).
The argument is not persuasive. As explained in the rejection above, the two sets of claims are drawn to the same method of treating depression (reference claims) and bipolar depression (instant claims) by administration via inhalation of a dry powder composition comprising same active agent, same bulking agent and same stabilizer/force control agent and wherein the method or the composition specifics are the same or very similar. The two sets of claims are not patentably distinguishable.
Claims 32-65 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616