DETAILED ACTION
The amendment submitted on November 7, 2025, has been entered. Claims 1, 5-15, and 17-19 are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
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.
Maintained/Modified Rejections Claim Rejections – 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obvious-ness 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) resolv-ing the level of ordinary skill in the pertinent art; and (4) considering objective evidence present in the application indicating obviousness or nonobviousness. See MPEP1 2141 et seq.
Claims 1 and 5-15 remain rejected and new claim 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Dolmetsch et al., WO 2019/025931 A1 in view of Lou et al., Acta Pharmacol. Sin. 2014;35(12):1485-92 and Smith et al., Eur. J. Pharmacol. 2004;492(2-3):137-42.
Dolmetsch (cited in the prior action) discloses the use of the mGluR5 antagonist mavoglu-rant in the reduction of drug use, specifically, cocaine use, as well as preventing relapse, promo-tion of abstinence, and treatment of psychiatric symptoms associated with drug use disorder (p. 1). The reference also discloses treating drug abuse associated with insufflation or inhalation (p. 5), comorbidity with a variety of psychiatric disorders (p. 6), combination treatment with psychological and computer-assisted behavioral therapy (p. 6), combination treatment with methadone or buprenorphine (p. 6), treating patient with genetic variation associated with substance abuse (p. 6), use of immediate- and modified-release dosage forms (p. 6), administra-tion of 200 mg of mavoglurant b.i.d. (p. 7), and treatment of binge drinking (p. 7), thereby suggesting the subject matter of claims 5-15. This treatment operates, at least in part, by antagonizing mGluR5 (pp. 2-3).
The difference between the prior art and the claims at issue is that Dolmetsch does not specifically disclose treating opioid use disorder. Instead, Dolmetsch is directed to treating cocaine use disorder.
Lou (cited in the prior action), however, discloses that antagonism of mGluR5 “suppresses the relapse to heroin-seeking and anxiety-like behavior” so “mGluR5 antagonists may be a potential candidate for the therapy of heroin addiction” (see abstract). Smith (also cited in the prior action) likewise discloses that mGlu5 antagonists reverse morphine tolerance in mice (see abstract). It would have been well known to one of skill in the art that heroin and morphine are opioids within the scope of the instant claims.
It would have been prima facie obvious to one of ordinary skill in the art as of the effective filing date to use the therapy of Dolmetsch in the treatment of opioid use disorder as taught by Lou and Smith and thereby arrive at subject matter within the scope of the instant claims. Apprised of the mGlu5 mechanism of action described in the three references, it would have been apparent that mavoglurant would also be useful for the treatment of heroin or morphine use disorder. In general, one would have viewed using an existing drug in accordance with its known or expected pharmaceutical properties and thereby arriving at a readily predictable outcome as being prima facie obvious. See, e.g., MPEP 2144.07 (selection of a known material based on its suitability for its intended use is generally considered to be prima facie obvious).
The therapeutic outcomes recited at the end of instant claim 1 would be inherent in the treatment outlined above. Mere recognition of such latent properties in the prior art does not render nonobvious an otherwise known invention. Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. The fact that applicant has appar-ently recognized certain therapeutic outcomes that would flow naturally from following the suggestion of the prior art “cannot be the basis for patentability when the differences would otherwise be obvious.” See MPEP 2145(II) (prima facie obviousness is not rebutted by merely recognizing additional advantages or latent properties present but not recognized in the prior art).
With respect to new claims 17-19, Dolmetsch discloses oral administration (p. 39, l. 1), the eleven characteristics of addiction recited in claim 18 (pp. 28-29), and administration with or without another active ingredient (pp. 33-34).
Response to Arguments
Applicant argues that only Dolmetsch concerns mavoglurant but is “directed to cocaine use disorder (CUD) and includes no[] teachings or reason to use mavoglurant for any treatment related to e.g., opioid use disorder, opioid relapse, heroin seeking, morphine tolerance, or any other opioid-related clinical indication.” Applicant similarly argues that Lou and Smith are studies with a different compound referred to as “MPEP.” See applicant’s Remarks, submitted Novem-ber 7, 2025, at p. 6. The examiner appreciates that none of the references by themselves fully discloses the claimed invention. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See MPEP 2145(IV). Applicant’s arguments concerning the teachings of the references when considered in isolations are therefore not persuasive.
Applicant further argues that Lou and Smith disclose “studies done only on rats.” Remarks at p. 6. But the experiments described in applicant’s own specification (pp. 50-53) were also conducted with rats. If evidence from rats is good enough for applicant, then it is unclear why the same sort of data in the cited references would be a problem. The examiner acknowledges that applicant’s specification (pp. 55-57) describes experiments that might be conducted using human patients, but these experiments are merely prophetic in nature, i.e., they were not actually conducted. See MPEP 2164.02 for a discussion of prophetic examples.
Applicant also mischaracterizes the examiner’s basis for rejection. Applicant states that “the rejection alleges that this is merely the substitution of one art recognized treatment for another and thus justified under MPEP § 2144.07.” See applicant’s Remarks at pp. 6-7. This is not—strictly speaking—the examiner’s position. Substitution of equivalents is discussed in 2144.06(II) (SUBSTITUTING EQUIVALENTS KNOWN FOR THE SAME PURPOSE). The rejection does not mention this section of the MPEP. Instead, it cites MPEP 2144.07, which stands for the proposition that it is prima facie obvious to use a known thing in accordance with its art-recog-nized utility. In any case, the examiner would come to the same conclusion whether the basis for rejection is under MPEP 2144.06(II) or 2144.07. Briefly, mavoglurant was known in the prior art mGluR5 antagonist for reduction of drug use (Dolmetsch) and mGluR5 agonists are also useful for use in opioid dependence (Lou and Smith). Either MPEP 2144.06(II) or 2144.07 supports the conclusion that using mavoglurant in the treatment of opioid dependence is prima facie obvious. Applicant’s assertion that “MPEP and mavoglurant are completely different molecules presenting multiple divergent functional groups” (Remarks at p. 7) does not alter the examiner’s conclusion.
Applicant also argues that “new claim 17 is directed to oral administration. No prior art reference is directed to oral administration of any compound to treat opioid use disorder especially in humans.” Remarks at p. 8. This is not persuasive because Dolmetsch discloses oral administration (p. 39, l. 1).
Finally, applicant argues that “the current application shows that mavoglurant, at half the dose of MPEP, produced a broader effect on the opioid relapse behavior. That is, mavoglurant at 10 mg/kg in the opioid model reduced cue-induced reinstatement, and that MPEP needed 20 mg/kg and had the narrower effect (see Example 3 of the application as filed).” Applicant is not claiming, however, any method in which the mavoglurant is administered at a dosage amount of 10 mg/kg.
Applicant’s arguments have been fully considered but are not persuasive. The rejection is accordingly maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
March 2, 2026
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024].