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 .
DETAILED ACTION
Claims 1-3, 5-7 and 18-37 are currently pending in the instant application. Applicants have amended claims 1, 3 and 5-7, canceled claims 4 and 8-17 and added new claims 18-37 in an amendment filed on May 23, 2025. Claims 1-3, 5-7, 19, 22-27, 30-33 are rejected, claims 18, 20, 21, 28, 29, 34, 36 are objected and claims 35 and 37 are considered allowable in this Office Action.
I. Priority
The instant application is a 371 of PCT/IB2023/052091, filed on March 6, 2023 which claims benefit of US Provisional Application 63/317,257, filed on March 7, 2022.
II. Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 5, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
III. Rejections
35 USC § 103 - OBVIOUSNESS REJECTION
The following is a quotation of 35 U.S.C. § 103(a) that forms the basis for all
obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Graham v. John Deere Co. set forth the factual inquiries necessary to determine obviousness under 35 U.S.C. §103(a). See Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Specifically, the analysis must employ the following factual inquiries:
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 1-3, 5-7, 19, 22-27, 30-33 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Golan (WO 2016/092546 A1) and Orio Ortiz, et al. (US 2019/0365676 A1). Applicants claim
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The Scope and Content of the Prior Art (MPEP §2141.01)
Golan teaches the use of 2-aminoindan derivatives for regulating binge behavior (i.e. binge drinking). The prior art teaches the species
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5-methoxy-2-aminoindan (see table A, compound 1, page 27).
Orio Ortiz, et al. teaches the use of OEA (i.e.
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palmitoylethanolamide, see paragraph 0126, page 8) for the relief and/or treatment of alcohol use or consumption disorders (see page 4, paragraph 0067).
The Difference Between the Prior Art and the Claims (MPEP §2141.02)
The difference between the prior art of Golan, the prior art of Orio Ortiz, et al. and the instant invention is that the prior art references do not teach the combination of the 2-aminoindan and PEA in a composition as seen in the instant claimed invention.
Prima Facie Obviousness-The Rational and Motivation (MPEP §2142-2413)
In In re Kerkhoven, 6 26 F. 2d 846, 205 USPQ 1069 (CCPA 1980), it was well established that it is obvious to combine individual compositions taught to have the same utility to form a new composition that is used for the very same purpose. The prior teaches individually the use of the compound 5-methoxy-2-aminoindan and palmitoylethanolamide for treating alcohol binge drinking or alcohol dependent disorders. It would be obvious for one of ordinary skill in the art to prepare a composition comprising the above known compounds for treating alcohol binge drinking or alcoholism with a reasonable expectation for success.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to prepare a composition comprising 5-methoxy-2-aminoindan and palmitoylethanolamide based on the teachings of the preferred embodiments in the prior art references and what has been already established in In re Kerkhoven. A strong prima facie obviousness has been established.
IV. Objections
Dependent Claim Objections
Dependent Claims 18, 20, 21, 28, 29, 34, 36 are also objected to as being dependent upon a rejected based claim. To overcome this objection, Applicant should rewrite said claims in an independent form and include the limitations of the base claim and any intervening claim.
V. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached on 7:00 AM-3:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626
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