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 .
Status of the Application
Applicant's election with traverse of Group I, drawn to a method of treating a subject afflicted with substance use disorder by administering a compound of formula I, in the reply filed on 3/19/26 is acknowledged. The Applicant also selects a species election for the compound of formula I. However, the Applicant failed to select a species election directed to the substance abuse disorder. In the interest of compact prosecution, the Examiner will make this species election. The traversal is on the grounds that the claims share a common inventive feature of having common structural features as well as sharing a common method of treating substance abuse disorder. This is not found persuasive because this common inventive feature is not a special technical feature since it does not make a contribution over the prior art. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-2, 6, 14, 16-18, 21, 24, 28-29, 36, 38, 40, 44-46, 53, 60, 64 are pending. Claims 18, 21, 24, 28-29, 36, 38, 40, 44-45 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-2, 6, 14, 16-17, 46, 53, 60, 64 are examined herein insofar as they read on the elected invention and species.
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 2 and 53 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Regarding claims 2 and 53, the phrase "including" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-2, 6, 14, 16-17, 46, 53, 60, 64 are rejected under 35 U.S.C. 103 as being unpatentable over Kruegel et al. (US Patent Application 2017/0334923, of record) in view of Friedhoff (US Patent Application 2015/0246055, of record).
The instant claims are directed to a method of treating a subject afflicted with substance use disorder by administering a compound of formula I.
Kruegel et al. teach a novel class of heteroarylazepines which are active as modulators of three opioid receptors (MOR, DOR, and/or KOR), therefore useful as anti-addictive agents (abstract, paragraphs 0861-0862) to humans. Pharmaceutically acceptable carriers are also taught (paragraph 0591). Specifically, both KOR agonists and antagonists have been known for their treatment in drug addiction and abuse (paragraph 0004). This class of compounds is also known as oxa-ibogamine analogs (paragraphs 0817 and 0829). A preferred compound is below (claim 27).
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It is noted that the above compound differs from the species election at the R1 position. The above compound shows an ethyl group at this position whereas the species election shows a methyl group. Where an alkyl group differs by only a single methylene group, they are considered homologs over one another, therefore obvious absent a showing of unexpected results.
It is well settled in patent law that the selection of a known material based on its suitability for its intended use is prima facie obvious. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). What's more, the prima facie obviousness is also supported by the holding that homologs are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
However, Kruegel et al. fail to disclose an opioid use disorder and the 10-500 mg dosage amount.
Friedhoff teaches methods of treating opioid or opioid-like drug addiction, including acute and post-acute withdrawal symptoms, by administering ibogaine or a ibogaine derivative (abstract), wherein the drug addiction is to morphine (paragraph 0005) and the dosage amount is 20-120 mg (paragraph 0157).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have used the compound, taught by Kruegal et al., in the method of treating opioid addiction, as taught by Friedhoff.
A person of ordinary skill in the art would have been motivated to use this compound to treat opioid addiction because this compound is known for treating drug addiction, in general. Furthermore, this compound is taught to be an oxa-ibogamine analog, which is known to be useful for treating opioid addiction. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in treating opioid addiction by administering this compound.
The limitations regarding “wherein the treating is effective for an extended time” and “wherein the effective amount of the compound administered to the subject without inducing cardiotoxicity, without inducing QT interval prolongation or without inducing cardiac arrhythmia” are obvious since all the elemental method steps have been taught or suggested by the cited prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (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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/Yong S. Chong/Primary Examiner, Art Unit 1623
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