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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election of species without traverse in the reply filed on 06/15/2026 is acknowledged.
Applicants elected compliant species of neurological condition: agitation associated with dementia.
Examiner did not find prior art for applicant elected species. Therefore Markush search was extended to species of treatment resistant depression(TRD). Therefore, Markush search was not extended further as Markush search practices.
Elected species read on claims 2, 13-14 and 26-36.
Claim 1 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/04/2026.
Current Status of 18/289,466
This Office Action is in response to the amended claims of 06/06/2024.
Claim 1 is original; and claim 2, 13-14 and 26-36 are currently amended.
Claims 1 is withdrawn.
Claims 2, 13-14 and 26-36 are examined.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 06/22/2026 and 07/27/2026. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Priority
Effected filing date is 05/14/2021.
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.
Claim(s) 2, 13, and 26-30 are rejected under 35 U.S.C. 102(a) (1)s being anticipated by Carney et.al. (US 8,785,500 B2).
Carney et.al teaches intranasal administration of the ketamine is sufficient to alleviate the effects of the treatment resistant depression (TRD) for 7 days (column 33, claim 6), (anticipating claim 2). The intranasal formulation will eliminate the necessity of patient presentation to a hospital or clinic for intravenous administration (column 7, last paragraph) (anticipating claims 13).
Claims 26-30 are drawn to inherent properties of intranasal administration of racemic ketamine to a patient. Since claim 2 is rejected, the examiner view claims 26-30 properties of the composition in used in the method claims of claim 2. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01(I). Teaching claims 26-30.
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.
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.
Claim(s) 2, 13-14 and 26-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Carney et.al. (US 8,785,500 B2).
In view of
Benedict et.al. (Pharm Res (2013) 30:2475–2484)
1. Determining the scope and contents of prior art.
Murrough et.al. teaches claim 2.
Chapman teaches intranasal administration, especially to the upper portion of the nasal cavity, has been shown to achieve direct CNS delivery of a variety of compounds without invasiveness or major complications. In addition, it causes rapid increases in CNS levels of these compounds (page 2476). Intranasal administration leads to significantly greater tissue-to-blood concentration ratios in all brain regions over 2 h as compared to intravenous (IV) administration(page 2479).
2. Ascertaining the differences between the prior art and the claims at issue.
Although Carney et.al teaches intranasal administration of racemic ketamine for treating TRD and decrease in hospitalization. Carney does not teach decrease faster resolving neurological condition, reduce side effect relative to equivalent dose intravenous administration of ketamine.
Although Benedict et. al. teaches intranasal administration of direct delivery to the central nervous system(CNS) of drug. Benedict et.al. does not teach intranasal administration of racemic ketamine to decrease in hospitalization, faster resolving neurological condition, reduce side effects relative to equivalent dose intravenous administration of ketamine.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill in the artisan who has sufficient training in administering pharmaceutical composition to central nervous system for treating neurological disorder
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to administer ketamine intranasally for treating TRD because intranasal administration drug for neurological disorder to achieve direct CNS delivery of a variety of compounds without invasiveness or major complications (Benedict page 2476) thus reducing the need for hospitalization (claim 13). Therefore, it would be expected intranasal administration of ketamine will also achieve direct delivery of ketamine to the CNS, without invasiveness of major complication. Furthermore, intranasal administration of ketamine is expected to resolve faster neurological condition due close proximity to the central nervous systems, thus teaching claim 14.
Claims 26-30 are drawn to inherent properties of intranasal administration of racemic ketamine to a patient. Since claim 2 is rejected, the examiner view claims 26-30 properties of the composition in used in the method claims of claim 2. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01(I). Teaching claims 26-30.
Conclusion
No claims are allowable as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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