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 161-180 are currently pending in the instant application. Applicants have canceled claims 1-160 and added new claims 161-180 in an amendment filed on February 12, 2024. Claims 161-175 and 177-180 are rejected and claim 176 is objected in this Office Action.
I. Priority
The instant application is a 371 of PCT/EP2022/064328, filed on May 25, 2022 which claims benefit of US Provisional Application 63/193,056, filed on May 25, 2021.
II. Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 24, 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
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.
Claims 161-164, 172, 173, 174, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pouget, et al. (WO 2016/170124 (A2)). The instant invention claims
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The Pouget, et al. reference teaches the use of NMDA antagonists (i.e., ketamine, see page 8, lines 4-8) for treating impulse control and addiction disorders including without limitation pyromania, kleptomania and compulsive gambling (see page 9). This species of disorders anticipates the genus disorder of the instant invention, wherein the genus disorder is behavioral addiction.
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 165-171, 175 and 177-180 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Pouget, et al. (WO 2016/170124 (A2)) in view of Grant, et al. (The Canadian Journal of Psychiatry, Vol. 58, No. 5, May 2013, pages 252-259). Applicants claim
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The Scope and Content of the Prior Art (MPEP §2141.01)
The Pouget, et al. reference teaches the use of NMDA antagonists (i.e., ketamine, see page 8, lines 4-8) for treating impulse control and addiction disorders including without limitation pyromania, kleptomania and compulsive gambling (see page 9). Pouget, et al. also teaches that ketamine can be administered in an amount of at least 0.7 mg/kg (see page 12, lines 16-19) as well as sublingually (see page 18, lines 11-14).
Grant, et al. references teaches examples of behavioral addictions including pathological gambling, kleptomania, pyromania, compulsive buying, compulsive sexual behavior, internet addiction and binge eating disorder. The prior art also teaches the cognitive behavioral therapy has been shown to be effective, for example, in significantly decreasing compulsive buying symptoms (see page 255). Grant, et al. further teaches that cognitive behavioral therapy can also be useful in treating certain types of behavioral addiction disorders such as compulsive buying and compulsive sexual disorder (see pages 254-255).
The Difference Between the Prior Art and the Claims (MPEP §2141.02)
The difference between the prior art of Pouget, et al. and the instant invention is that Pouget, et al. broadly teaches that ketamine can be useful in treating impulse control and addiction disorders including pyromania, kleptomania and compulsive gambling but does not specifically teach addiction disorders such as compulsive sexual disorder, internet addiction, etc. The definition of impulse control and addiction disorders is nonlimiting according to the Pouget, et al reference. The Grant, et al. reference teaches that compulsive sexual disorder, internet addiction, etc. falls under addiction disorders.
Prima Facie Obviousness-The Rational and Motivation (MPEP §2142-2413)
Pouget, et al. teaches the ketamine is useful in treating impulse control and addiction disorders and specifically list pyromania, kleptomania and compulsive gambling as examples but the definition is broad and is nonlimiting which includes other disorders which fall under this genus of disorders. The Grant, et al. teaches additional examples of addiction disorders such as compulsive sexual disorder, internet addiction, etc. falls under addiction disorders that were well known at the time that the claimed invention was filed. It would be within the knowledge of one of ordinary skill in the art to understand that all impulse control and addiction disorders would be treatable by administering ketamine based on the teachings of Pouget, et al. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to use ketamine to treat other addiction disorders not specifically listed in the Pouget, et al. reference based on the teachings of the preferred embodiments in the prior art. For example, a skilled artisan would be motivated to use ketamine for treating internet addiction based on the teachings of Pouget, et al. in view of Grant, et al. A strong prima facie obviousness has been established.
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 173 and 174 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 173 and 174 recites limitations that refer to gambling disorder which depends on claim 166. Claim 166 contains the limitation “wherein the behavioral addiction is gaming disorder”. According to claim 164 “gaming disorder” is different and separate from “gambling disorder”. The limitation of claim 166 does not refer to “gambling disorder” as seen in claims 173 and 174. There is insufficient antecedent basis for this limitation in these claims. Applicants are suggested to amend claims 173 and 174 so that they depend on claim 172 instead of 166 to overcome the rejection.
IV. Objections
Dependent Claim Objections
Dependent Claim 176 is 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.
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/SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626
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