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
This is a response to Applicant’s communication filed on June 8, 2026. Application No. 18/266,917, is a 371 of PCT/IB2021/061506, filed December 9, 2021, and claims the benefit of U.S. Provisional application No. 63/125,181, filed December 14, 2020. In an amendment filed July 8, 2026, Applicant added new claims 25-27. Claims 1-27 are pending.
Rejection Withdrawn
The rejection of claims 6-10 and 14 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention, because the phrases "such as", “for example”, “in particular”, and “e.g.” render the claims indefinite is withdrawn in view of Applicant’s June 8, 2026, Amendment & Remarks.
Rejections Maintained
Claim Rejections - 35 USC § 112(b)
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 rejection of claims 11 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention is maintained for reasons made of record. The phrase “for example wherein the further active agent is an antidepressant or an anxiolytic” renders the claim indefinite because it is unclear whether the limitations following the phrase “for example” is part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The rejection of claims 1-24, as well as new claims 25-27 under 35 U.S.C. 112(a) because the specification, while being enabling for a method of treatment for gambling and/or gaming disorder, the specification does not reasonably provide enablement for a method to prevent relapse into gambling or gaming disorder, is maintained for reasons made of record. Applicant argues that the present disclosure taken as a whole enables a method of preventing relapse into gambling (gaming) disorder; the amount of direction provided by the application as filed is sufficient, at least because the specification identifies the drug, patient population, clinical endpoints, assessment methods, and results showing comparative effectiveness against other drugs. Applicant’s argument has been fully considered and is not persuasive.
Applicant argues that the disclosure taken as a whole enough to enable the prevention of relapse into gambling or gaming disorder. Applicant points to Example 1 of the present specification. Example 1 is drawn to a study with patients having a positive family history (FHP) of alcohol use disorder (AUD) compared with patients having a negative family history (FHN) of AUD. Functional magnetic resonance imaging (fMRI) data is analyzed from the patients groups from both before and after given “monetary incentive delay tasks” (MIDTs) to measure the effect of mavoglurant. No patients were identified as having gambling/gaming disorder as defined by the present specification.
In this case, there is no correlation between the fMRIs findings and gambling/gaming disorders. Contrary to applicant’s suggestion there is no difference from what is known in the art. Although the fMRI data appears to suggest a correlation between FHP and FHN patients and the effect of mavoglurant administration on AUD. It is unclear how the data demonstrates a correlation between mavoglurant and its effect on gambling/gaming disorder, let alone a correlation between mavoglurant and preventing relapse into gambling/gaming.
mGluR5s like mavoglurant are known to treat substance tolerance or dependence. See Corse et al., US2003/0195139 A1, Abstract. The present invention merely takes a subset of individuals known to have a substance tolerance or dependencies disorders (i.e., AUD) which is known to be treatable with mavoglurant and implies that the same set of individuals also have gambling/gaming disorder(s) and therefore treatable.
In this case, there is no correlation between mGluR5 antagonism and preventing relapse into gambling or gaming disorder. Accordingly, it would require undue experimentation for the artisan to practice the invention as broadly claimed.
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.
The rejection of claims 1-24, as well as new claims 25-27 under 35 U.S.C. 103 as being unpatentable over Harpsøe et al., Selective Negative Allosteric Modulation of Metabotropic Glutamate Receptors – A Structural Perspective of Ligands and Mutants, 5(11) Scientific Reports, 13869 (publ’d September 11, 2015) in view of Corse et al., US2003/0195139 A1, is maintained for reasons made of record. Applicant argues that the prior art does not disclose a treatment of gambling disorder or gaming disorder as claimed by the present invention. Applicant’s argument has been fully considered and is not persuasive.
Applicant argues that Harpsøe does not disclose monetary incentive delay task (MIDT), nor experimental or clinical results in reward processing relevant for gambling or gaming, normalization of ventral striatal activity , or any clinical patient population relevant to the claimed invention. Similarly, however, as stated in the 35 U.S.C. 112(b), enablement rejection above, the basis for treating gambling or gaming disorders as claimed by the present invention is in experimental and clinical results of the effects of mavoglurant on patients who have a family history of AUD; not gambling or gaming disorders. The treatment of gambling and gaming disorders as claimed by the present invention encompasses those conditions known to be treated in the art. See Specification, p. 38, Conclusion, “Alcohol use disorder (AUD) . . . show differences in A1 and A2 phases of reward processing . . ..”
Again, Harpsøe teaches that mavoglurant is a mGluR5 allosteric modulator. See Harpsøe et al., p. 2, Table 1. Harpsøe also teaches that metabotropic glutamate receptors have wide range of modulatory functions in the central nervous system. Id., p. 1. Abstract. Again, like the basis for treating gambling or gaming disorder as claimed by the present invention, Harpsøe discloses treating nervous system disorders including drug and alcohol abuse (i.e., AUD). Id., para. [0338].
As claimed by the present invention, Corsi teaches that mGluR5 antagonist are useful in tolerance or dependence therapy.. Corsi et al., US PG Publc’n ‘139, Abstract. Furthermore, mGluR5 can be used to treat substance tolerance or dependence, including gambling dependence or obsessive compulsive disorders. Id.; see also Id., p. 7, para. [0018]; and Id., p. 8 claim 26.
The present invention merely treats disorders known in the art to be treatable with mavoglurant (i.e., AUD). The difference between the prior art and present invention is whether those disorders are associated with gambling or gaming disorder. The prior art clearly teaches treating the disorders which fall within applicant’s definition of gambling and gaming disorder. In fact, Corsi directly suggest treating gambling and gaming disorder. Id. To the extent that treating gambling or gaming disorder is enabled by the present invention, the disclosure of the prior art provides more than an expectation of success.
Laslty, with respect to the methods of administration of the dependent claims of the present invention, see Id., para. [0122]-[0129]. Accordingly, all the elements of the present invention are disclosed in the prior art.
It would have been obvious to the ordinary artisan at the time of the invention to treat gambling and/or gaming disorders with the mGluR5 antagonist, mavoglurant. Harpsøe teaches that mavoglurant is an mGluR5 antagonist. Corsi teaches that mGluR5 antagonist are used to treat gambling and/or gaming disorder as generally claimed the present invention. In this case the present invention combines prior art elements according to known methods to yield
predictable results.
It is suggested that applicant provide data supporting a relationship/correlation between the administration of mavoglurant and treating gambling or gaming disorder; more than evidence of treating the disorders (as disclosed in the prior art) that may be associated with gambling or gaming disorders.
Conclusion
No claims are allowed.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625
Prosecution Insights