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 .
Election/Restrictions
Applicant's election with traverse of an amphetamine-type stimulant in the reply filed on 2/5/2026 is acknowledged. The traversal is on the ground(s) that the claims are directed to a single general inventive concept and do not present patentably distinct species requiring separate searches and separate examinations. Applicants submit that the “stimulant use disorder” and “amphetamine-type stimulant” set forth in the specification is not arbitrary nor open-ended. This is not found persuasive because there are differences in the core structure that requires multiple searches, which would be undue burden.
The requirement is still deemed proper and is therefore made FINAL.
Current Status of 18/266,427
This Office Action is responsive to the amended claims of 6/9/2023.
Claims 1-19 are examined on the merits.
Priority
This application is a national stage entry of PCT/IB2021/061503 and claims priority to US provisional application 63/124,565.
The instant claims find support from the provisional application. Therefore, the effective filing date is 12/11/2020.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 06/09/2023, 10/17/2023, 10/31/2025, and 12/01/2025, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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 7, 9, 11, 12, and 15 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.
Regarding claims 7 and 15, the phrases "such as" 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).
Regarding claim 12, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 9, 11, and 15, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
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.
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. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 6-8, 14, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over GASS (Gass et al., “mGluR5 antagonism attenuates methamphetamine reinforcement and prevents reinstatement of methamphetamine seeking behavior in rats”, Neuropsychopharmacology, March 2009, previously cited by applicants) and in view of WO 2019/025932.
GASS teaches mGluR5 antagonism attenuates methamphetamine (the elected species of amphetamine-type stimulant) reinforcement and prevents reinstatement of methamphetamine-seeking behavior in rats (subject) (title).
GASS teaches that MTEP (an mGluR5 antagonist) dose-dependently reduced the reinforcing effects of methamphetamine (Abstract). GASS teaches that MTEP also dose-dependently prevented cue and drug-induced reinstatement of methamphetamine-seeking behavior (abstract). GASS teaches that pharmacological inhibitors of mGluR5 receptor function may represent a novel class of potential therapeutic agents for the treatment of methamphetamine addiction (abstract). This helps teach claims 1-3, and 17-18 (methamphetamine).
GASS teaches that the 3 mg/kg dose of MTEP significantly reduced the number of active lever presses and number of infusions delivered in each group (Figure 1A and 1C). This helps teach claim 2.
GASS teaches “Our observations that MTEP attenuated methamphetamine self-administration under both FR and PR schedules of reinforcement underscores the notion that mGluR5 antagonism attenuates the reinforcing effects of this psychostimulant, and such ligands may be of potential clinical benefit in the treatment of methamphetamine addiction” (page 10). This helps teach claim 1.
GASS teaches the amphetamine-type stimulant use is intravenous injection and oral ingestion (i.e. food pellet) (page 4). This teaches claim 6. Additionally, an intravenous injection is immediate release dosage and the food is a modified release dosage of claim 14. This teaches claim 14.
GASS teaches that there is a high degree of comorbidity of other psychiatric disorders in methamphetamine users (page 2). This helps teach psychiatric disorder of claim 7.
GASS teaches that current methods for the treatment for methamphetamine addiction include psychosocial or cognitive-behavioral therapy in inpatient and outpatient settings (page 2). This helps teach claim 8.
GASS teaches that MTEP appeared to be more efficacious in preventing reinstatement of methamphetamine-seeking behavior, as effects at both the 1 and 3 mg/kg were observed (page 11). This helps teach claim 3.
GASS does not teach mavoglurant.
WO 2019/025932 teaches the mGluR5 antagonist named mavoglurant (page 1).
The artisan would have been motivated to substitute mGluR5 antagonist (MTEP) (GASS) with another mGluR5 antagonist (mavoglurant) (WO 2019/025932 page 1). The artisan would expect that one mGluR5 antagonist (MTEP) would behave similarly as another mGluR5 antagonist (mavoglurant) since both are mGluR5 antagonist.
GASS teaches that mGluR5 antagonism prevents reinstatement of methamphetamine-seeking behavior in rats (subject) (title). The artisan would expect that mavoglurant administered to a subject would also prevents reinstatement of methamphetamine-seeking behavior. This teaches claim 3. Examiner also understands preventing reinstatement of methamphetamine-seeking behavior as promotion of substance abstinence. This teaches claim 4.
The artisan would further be motivated to use mavoglurant in a method of reducing substance use. The artisan would expect that the mGluR5 antagonist to reduce the number of active lever presses and number of infusions delivered (i.e. reducing drug usage) (GASS Figure 1A and 1C). This teaches claim 2.
Furthermore, the artisan would have been motivated to use mavoglurant in a method of treating substance use disorder. GASS teaches that pharmacological inhibitors of mGluR5 receptor function may represent a novel class of potential therapeutic agents for the treatment of methamphetamine addiction (abstract). The artisan would expect that a mGluR5 antagonist to attenuated methamphetamine self-administration (page 10). This teaches claims 1, 17-18.
GASS teaches the amphetamine-type stimulant use is intravenous injection and oral ingestion (i.e. food pellet) (page 4). The artisan would have been motivated and expected to use the known route of administration. This teaches claim 6.
It is obvious to administer the substance use disorder treatment (mavoglurant) to any patient who has a substance use disorder, including a sub-population that has a comorbidity of claim 7 (GASS page 2) or a sub-population of mild/moderate/severe usage, because nothing precludes them from the treatment. This teaches claims 7 and 19.
The artisan would have found it obvious to combine psychosocial or cognitive-behavioral therapy, which is known to be a treatment for substance use disorder treatment (GASS page 2), with mavoglurant, another known treatment for substance use disorder treatment. It is prima facie obvious to combine one substance use disorder treatment with another in order to form a treatment to be used for the very same purpose (treating a substance use disorder). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I). This teaches claim 8.
Claim(s) 1-8, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over GASS (Gass et al., “mGluR5 antagonism attenuates methamphetamine reinforcement and prevents reinstatement of methamphetamine seeking behavior in rats”, Neuropsychopharmacology, March 2009) and in view of WO 2019/025932, and in view of Rehab (“Meth Addiction and Depression”, Rehab Center, March 15, 2019) and as evidenced by BLAKER (Blaker et al., “Methamphetamine-Induced Brain Injury and Alcohol Drinking”, J Neuroimmune Pharmacol, March 1, 2019) and as evidenced by DRUG HUNTER (“PK Cheat Sheet”, Drug Hunter, August 11, 2025).
Claims 1-4, 6-8, and 17-18 are taught above.
Rehab teaches that meth usage can cause depression (page 1).
An artisan would assume that by treating methamphetamine usage (which for some can cause depression), depression would also improve (after a time). This teaches claim 5.
BLAKER is relied upon for the beneficial teaching that a majority of methamphetamine (Meth) abusers also abuse alcohol (abstract).
It is obvious to administer the substance use disorder treatment (mavoglurant) to any patient who has a substance use disorder, including a sub-population that also abuses alcohol, because nothing precludes them from the treatment. This teaches claim 16.
DRUG HUNTER is relied upon for the beneficial teaching that an average human is 70 kg (“Physiological Parameters Figure”).
GASS teaches administering MTEP (0.3, 1, or 3 mg/kg) (page 4). Examiner calculates a human sized dose of 210 mg per day. This falls within the range of claim 15.
Claim(s) 1-4, 6-8, 11-13, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over GASS (Gass et al., “mGluR5 antagonism attenuates methamphetamine reinforcement and prevents reinstatement of methamphetamine seeking behavior in rats”, Neuropsychopharmacology, March 2009) and in view of WO 2019/025932, and in view of STAFFORD (Stafford et al., “Taar1 gene variants have a causal role in methamphetamine intake and response and interact with Oprm1”, Genetics and Genomics, August 5, 2019) and in view of NEWTON (Newton et al., “Bupropion reduces methamphetamine-induced subjective effects and cue-induced craving”, Neuropsychopharmacology, November 23, 2005).
Claims 1-4, 6-8, and 17-18 are taught above.
STAFFORD teaches that Taar1 genotype has a major impact on methamphetamine consumption, and gene mapping results demonstrate that a chromosome 10 QTL, at the location of Taar1, accounts for as much as 60% of the genetic variance in risk for MA intake (introduction).
It is obvious to administer the substance use disorder treatment (mavoglurant) to any patient who has a substance use disorder, including a sub-population that has a genetic variation associated with a substance use disorder, because nothing precludes them from the treatment. This teaches claim 13.
NEWTON teaches that Bupropion reduces methamphetamine-induced subjective effects and cue-induced craving (title). This helps teach claims 11-12.
The artisan would have found it obvious to combine Bupropion, which is known to be a treatment for substance use disorder treatment (NEWTON title), with mavoglurant, another known treatment for substance use disorder treatment (GASS title). It is prima facie obvious to combine one substance use disorder treatment with another in order to form a treatment to be used for the very same purpose (treating a substance use disorder). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I). This teaches claims 11-12.
Claim(s) 1-4, 6-8, 11-13, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over GASS (Gass et al., “mGluR5 antagonism attenuates methamphetamine reinforcement and prevents reinstatement of methamphetamine seeking behavior in rats”, Neuropsychopharmacology, March 2009) and in view of WO 2019/025932, and in view of Dallery (Dallery et al., “Technology-Based Contingency Management in the Treatment of Substance-Use Disorders”, Perspect Behav Sci., July 9, 2019).
Claims 1-4, 6-8, and 17-18 are taught above.
Dallery teaches that Contingency management is one of the most efficacious interventions to promote drug abstinence (abstract). Dallery also teaches using a computer based therapy (Internet-based Contingency Management). This helps teach claims 9 and 10.
The artisan would have been motivated to use a more efficacious type of therapy and a more convenient type of therapy (computer/internet based). The artisan would be expected to include therapy in the treatment (GASS page 2). The artisan would be further expected to use internet-based Contingency Management, as is one of the most efficacious interventions to promote drug abstinence (Dallery abstract). This teaches claims 9-10.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6-8, 14, and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US12201612 in view of GASS (Gass et al., “mGluR5 antagonism attenuates methamphetamine reinforcement and prevents reinstatement of methamphetamine seeking behavior in rats”, Neuropsychopharmacology, March 2009, previously cited by applicants). The reference claims teaches the instant compound and in view of GASS teaches the instant claims.
Reference claim 1 teaches mavoglurant (page 1) used in a method. Reference patent paragraph [0002] teaches mavoglurant as a mGluR5 antagonist.
GASS does not teach mavoglurant.
GASS teaches mGluR5 antagonism attenuates methamphetamine (the elected species of amphetamine-type stimulant) reinforcement and prevents reinstatement of methamphetamine-seeking behavior in rats (subject) (title).
GASS teaches that MTEP (an mGluR5 antagonist) dose-dependently reduced the reinforcing effects of methamphetamine (Abstract). GASS teaches that MTEP also dose-dependently prevented cue and drug-induced reinstatement of methamphetamine-seeking behavior (abstract). GASS teaches that pharmacological inhibitors of mGluR5 receptor function may represent a novel class of potential therapeutic agents for the treatment of methamphetamine addiction (abstract). This helps teach claims 1-3, and 17-18 (methamphetamine).
GASS teaches that the 3 mg/kg dose of MTEP significantly reduced the number of active lever presses and number of infusions delivered in each group (Figure 1A and 1C). This helps teach claim 2.
GASS teaches “Our observations that MTEP attenuated methamphetamine self-administration under both FR and PR schedules of reinforcement underscores the notion that mGluR5 antagonism attenuates the reinforcing effects of this psychostimulant, and such ligands may be of potential clinical benefit in the treatment of methamphetamine addiction” (page 10). This helps teach claim 1.
GASS teaches the amphetamine-type stimulant use is intravenous injection and oral ingestion (i.e. food pellet) (page 4). This teaches claim 6. Additionally, an intravenous injection is immediate release dosage and the food is a modified release dosage of claim 14. This teaches claim 14.
GASS teaches that there is a high degree of comorbidity of other psychiatric disorders in methamphetamine users (page 2). This helps teach psychiatric disorder of claim 7.
GASS teaches that current methods for the treatment for methamphetamine addiction include psychosocial or cognitive-behavioral therapy in inpatient and outpatient settings (page 2). This helps teach claim 8.
GASS teaches that MTEP appeared to be more efficacious in preventing reinstatement of methamphetamine-seeking behavior, as effects at both the 1 and 3 mg/kg were observed (page 11). This helps teach claim 3.
The artisan would have been motivated to substitute mGluR5 antagonist (MTEP) (GASS) with another mGluR5 antagonist (mavoglurant) (reference claim 1 and page 1). The artisan would expect that one mGluR5 antagonist (MTEP) would behave similarly as another mGluR5 antagonist (mavoglurant) since both are mGluR5 antagonist.
GASS teaches that mGluR5 antagonism prevents reinstatement of methamphetamine-seeking behavior in rats (subject) (title). The artisan would expect that mavoglurant administered to a subject would also prevents reinstatement of methamphetamine-seeking behavior. This teaches claim 3. Examiner also understands preventing reinstatement of methamphetamine-seeking behavior as promotion of substance abstinence. This teaches claim 4.
The artisan would further be motivated to use mavoglurant in a method of reducing substance use. The artisan would expect that the mGluR5 antagonist to reduce the number of active lever presses and number of infusions delivered (i.e. reducing drug usage) (GASS Figure 1A and 1C). This teaches claim 2.
Furthermore, the artisan would have been motivated to use mavoglurant in a method of treating substance use disorder. GASS teaches that pharmacological inhibitors of mGluR5 receptor function may represent a novel class of potential therapeutic agents for the treatment of methamphetamine addiction (abstract). The artisan would expect that a mGluR5 antagonist to attenuated methamphetamine self-administration (page 10). This teaches claims 1, 17-18.
GASS teaches the amphetamine-type stimulant use is intravenous injection and oral ingestion (i.e. food pellet) (page 4). The artisan would have been motivated and expected to use the known route of administration. This teaches claim 6.
It is obvious to administer the substance use disorder treatment (mavoglurant) to any patient who has a substance use disorder, including a sub-population that has a comorbidity of claim 7 (GASS page 2) or a sub-population of mild/moderate/severe usage, because nothing precludes them from the treatment. This teaches claims 7 and 19.
The artisan would have found it obvious to combine psychosocial or cognitive-behavioral therapy, which is known to be a treatment for substance use disorder treatment (GASS page 2), with mavoglurant, another known treatment for substance use disorder treatment. It is prima facie obvious to combine one substance use disorder treatment with another in order to form a treatment to be used for the very same purpose (treating a substance use disorder). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I). This teaches claim 8.
Conclusion
No claims are allowed as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625