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 13, 2023. 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. Claims 1-24 are pending.
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.
Claims 6-11 and 14 are rejected 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. The phrases "such as", “for example”, “in particular”, and “e.g.” render the claims indefinite because it is unclear whether the limitations following the phrase(s) are 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.
Claims 1-24 are rejected 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. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Factors to be considered when determining whether claims in an application for patent are enabling include (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.08, citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The claims include a method for preventing relapse into gambling or gaming disorder via the administration of mavoglurant. The specification teaches that mavoglurant is a mGluR5 antagonist and suggests that it may be used to treat diseases associated with mGluR5 antagonism. (Specification, all.) There are no specific examples demonstrating how mavoglurant can treat these conditions. However, as shown below, it was known at the time of the invention to treat gambling or gaming disorder using an mGluR5 antagonist. Notably, the specification is silent on how mGluR5 antagonism could prevent relapse into gambling and/or gaming disorder. In addition, the prior art fails to provide compensatory guidance. 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.
Claims 1-24 are rejected 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) (cited on the June 13, 2023, IDS), in view of Corse et al., US2003/0195139 A1. 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. The difference between Harpsøe and the present invention is the use of mavoglurant, as an mGluR5 modulator in the treatment of gambling and/or gaming disorder 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. Therefore 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. 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.
Conclusion
No claims are allowed.
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..
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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.
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625
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