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 .
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 61-73 and 75-80 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weinstein et al., Pharmacological Treatment of Cannabis Dependence, Curr Pharm Des. 2011; 17(14): 1351–1358 (“Weinstein”).
Weinstein relates to pharmacological treatment of cannabis dependence.
“Section 3.2.” pertains to the “Antagonist Approach”. Weinstein discloses that: “The antagonist approach uses long-term treatment with a CB1 antagonist to prevent patients from experiencing the pleasurable reinforcing effects of cannabis use, resulting in extinction of drug-seeking and drug-taking behavior. . . A recent randomized, double blind, parallel group study investigated whether subacute (2 week) treatment with the CB1 receptor antagonist rimonabant (40 mg daily) attenuated the effects of smoked cannabis in 42 healthy men with a history of cannabis use [54]. The repeated daily rimonabant doses attenuated the acute cardiovascular effects of a cannabis cigarette (2.78% THC) to a similar degree as a single 90-mg dose; repeated 40-mg doses attenuated subjective effects after 8 but not 15 days (possibly because of smaller sample size and lower statistical power at day 15). Rimonabant did not significantly affect THC pharmacokinetics, suggesting that the observed effects were due to receptor blockade and not reduced THC levels in the brain.” (p. 5).
It is noted that the above section discloses co-administration of both a CB1 antagonist (rimonabant) and a CB1 agonist (THC), per Applicant’s claims.
Further to that, the prior section “3.1. Agonist Approach” further outlines the use of a CB1 agonist. “One strategy to treat drug dependence is long-term treatment with the same agonist drug or with a cross-tolerant drug to suppress withdrawal and drug craving. This approach is successfully used in the treatment of tobacco (nicotine) dependence (nicotine itself) and opiate dependence (methadone, buprenorphine). It is being studied for treatment of cannabis dependence using synthetic THC which is legally marketed in many countries as an oral medication for appetite stimulation and suppression of nausea and vomiting due to chemotherapy. . . Use of oral synthetic THC in outpatients was reported in a study that showed the potential benefit, as well as questions that arise from the use of this medication in cannabis-abusing populations [52]. Controlled clinical trials of oral THC are currently underway (www.clinicaltrials.gov).” Elsewhere, Weinstein further discloses a study showing suppression of with withdrawal symptoms in the laboratory with a single dose of 10 mg/day oral synthetic THC (dronabinol) given to cannabis users. (p. 4).
Weinstein further specifically calls “cannabis use disorders”. (p. 5, last paragraph). This disclosure anticipates Applicant’s claims 61-65, 71-73, 75-77, 79. With respect to claims 72 and 79, it is further noted that since Weinstein discloses a CB1 antagonist, as per Applicant’s claims, it will have the same half-life of at least 2 hours, and capable of delivering an effective amount of the CB1 inhibitor in no more than 10 min.
Weinstein further discloses the use of anti-depressants, which were evaluated in clinical trials, e.g. the norepinephrine reuptake inhibitor atomoxetine (25-100 mg/day) (section 3.3.d), the anti-depressants nefazodone (300 mg/day), bupropion-sustained release (150 mg/day) (Section 3.3.g.). Weinstein further discloses that buspirone has shown efficacy for cannabis dependence in a controlled clinical trial. (Abstract). Weinstein also discloses clinical studies for cannabis use disorder with fluoxetine (20 mg daily). (p. 8). Weinstein also discloses studies with mirtazapine in participants who smoked active THC. (p. 4-5).
Table 1 also discloses and summarizes multiple drugs according to Applicant’s claims. (p. 14-15). Since it is in reference to pharmacological trials with indicated doses in mg, it is clearly that the drugs were supplied as tablets or capsules, which can further be evidenced by the cited references.
Since Weinstein discloses the same drugs as in Applicant’s claims, they will necessarily be metabolized by different enzymes in vivo, and the same antidepressant is metabolized primarily by CYP3A4.
Regarding claim 78, it is noted that specification does not define what is “a pharmaceutically acceptable alkaline agent”, nor does it give any examples of it. Accordingly, the broadest reasonable interpretation of this claim has been made. Other disclosed mood stabilizers in Weinstein are e.g. litihium carbonate, which is a pharmaceutically acceptable alkaline agent. (Section 3.3.f., ref. 81).
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.
Claim 74 is rejected under 35 U.S.C. 103 as being unpatentable over Weinstein et al., Pharmacological Treatment of Cannabis Dependence, Curr Pharm Des. 2011; 17(14): 1351–1358 (“Weinstein”), as applied to claims 61-73 above, and further in view of STN document No. 151:278314, corresponding to Janero et al., Cannabinoid receptor antagonists: pharmacological opportunities, clinical experience, and translational prognosis, Expert Opinion on Emerging Drugs (2009), 14(1), 43-65 (“Janero”).
Weinstein is discussed in the 35 USC 102(a)(1) rejection above.
Weinstein does not specifically disclose that the CB1 inhibitor has the structure of Applicant’s claim 74.
Janero is a review of cannabinoid receptor antagonists. It expands on the structures of known ones, to include rimonabant (also disclosed by Weinstein), and 1-Azetidinecarboxamide, 3-[(R)-(4-chlorophenyl)[2-(trifluoromethyl)phenyl]methoxy]-N-(1,1-dimethylethyl)-, claimed by Applicant in claim 74.
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Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to combine the teachings of Weinstein and Janero in order to practice Applicant’s claimed invention with a reasonable expectation of success. The skilled artisan would have been motivated to do so since Weinstein is broadly directed to any CB1 antagonist (“Section 3.2.” pertains to the “Antagonist Approach”. Weinstein discloses that: “The antagonist approach uses long-term treatment with a CB1 antagonist to prevent patients from experiencing the pleasurable reinforcing effects of cannabis use, resulting in extinction of drug-seeking and drug-taking behavior.). The skilled artisan would have been further motivated to do so since Janero expands the list of such known CB1 antagonists, which includes a compound according to claim 74. This creates motivation to select any further known CB1 antagonist of Janero for use in the method of treating addiction of Weinstein.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627
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