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 January 5, 2024. Application No. 18/576,990, is a 371 of PCT/EP2022/069204, filed July 8, 2022, and claims foreign priority to European Patent application No. EP 21305942.1, filed July 8, 2021. In a preliminary amendment filed January 5, 2024, Applicant cancelled claims 1-15 and added new claims 16-34. Claims 16-34 are pending.
Claim Rejections - 35 USC § 102(a)(1)
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 16-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Riga et al., U.S. Patent 6,174,890. The claims as presently construed are broad. Nonetheless, Riga discloses a method of treatment of circadian rhythm sleep disorders and/or circadian rhythm sleep neurological diseases and/or any medical condition associated due to sleep deprivation and/or circadian rhythm disruption and/or central disorders of hypersomnolence, comprising the administration of adafenoxate (i.e., melafenoxate), as generally and broadly claimed by the present invention. See ‘890 patent, Col. 15, ln. 10-16, for adafenoxate; see Id., Col. 12, lns. 20-25, for regulating sleep disorders.
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 16-34 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for a method of treating circadian related disorders, the specification does not reasonably provide enablement for preventing such disorders. 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 are drawn to preventing circadian rhythm sleep disorders. The specification generally concludes that melafenoxate (i.e., adafenoxate, a known nootropic agent) is a melatonin 1 (MT1) receptor agonist. (Specification, p. 8, lns. 8-12.) Other than this general statement, there is no data to support the claim that melafenoxate is in fact a MT1 agonist. More notably, even presuming melafenoxate is such a MT1 agonist, there is no direction on how MT1 agonism can prevent any circadian rhythm sleep disorder. The prior art fails to provide compensatory guidance. In this case, there is no correlation between MT1 agonism and preventing circadian rhythm sleep disorders. Accordingly, it would require undue experimentation for the artisan to practice the invention as broadly claimed.
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..
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