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 without traverse of Group I (drawn to a compound/pharmaceutical
composition), in the reply filed on 11/20/2024 is acknowledged.
Claims 1-6, 8-11, 13-19, and 31-32 are pending of which claims 13-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected INVENTION, there being no allowable generic or linking claim. The restriction requirement is still deemed proper and is made Final.
Pending claims 1-6, 8-11, and 31-32 have been examined on the merits.
Please note, for clarity of the record, Applicant’s election of species, 7-chloro-6-fluoro-l-(4-fluoro-2-methylphenyl)-3-(2-methyl-6-oxo-l,6-dihydropyridin-3-yl)-2,3-dihydroquinazolin-4(1H)-one, is recited in claims 1-3, 5-6, 8, 8, 10-11 and has the following structure:
PNG
media_image1.png
428
434
media_image1.png
Greyscale
Please also note in the interest of compact prosecution, that during the course of examination any prior art identified that relates to non-elected subject matter is applied to demonstrate the non-allowability of the generic claims and/or as discussed below.
Withdrawn Restrictions/Elections Requirement
The restriction for claims 13-19 has been withdrawn, thus claims 13-19 are now included for full examination on the merit.
Withdrawn Rejections
The rejection of claims 1-3, 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (J. Photochem. Photobiology Chem., 2017, 355, 25–31) is withdrawn in view of the amendments.
The rejection of claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Li . (J Photochem Photobiology Chem, 2017) as applied to claims 1-3, 5-6 above, and in view of Bowden et al. (J. Chem. Res., Synop., 1991, 11, 305) is withdrawn in view of the amendments.
Claim 1-6, and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Li (J Photochem Photobiology Chem, 2017) and Bowden (J. Chem. Res., Synop, 1991, 11, 305) as applied to claims 1-6 above, in view of JP-49045086 (1974) and Badolato et al. (RSC Adv. 2018 Jun 7;8(37):20894-20921) as evidence by Zhang et al. (Bioorg. Med. Chem. Lett.) 2021 Apr 15;38:127849.
Claim Rejections - 35 USC § 112 (Enablement)
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 following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 14-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention recites compound of formula (XIV) and a method of treating pain caused by trauma; or pain caused by iatrogenic, medical or dental procedures, as an example. However, the specification (page 150-151) discloses an in vitro assay, demonstrating the compounds’ ability to inhibit Nav1.8 sodium channel or currents in modified HEK293 cells using QPatch 48 HTX system, by measuring P2 current reduction and then calculating IC50 to inhibit Nav1.8. However, such an assay would not be considered a reliable test procedure to a person of ordinary skill in the art (POSITA), as evidence for assessing pain treatment. Therefore, the specification fails to provide any reliable data demonstrating that any compound encompassed by the claimed formula is effective in treating the specified condition. In fact, according to European Pain Federation (EFI, page 1) discloses the following regrading pain management:
PNG
media_image2.png
122
682
media_image2.png
Greyscale
EFI (page 1-2) also provides an overview of commonly recommended measures (e.g. visual pain scale, pain chart faces) that clinicians can use to aid their assessment of a patient’s pain:
PNG
media_image3.png
390
568
media_image3.png
Greyscale
The specification does not provide any working examples similar to EFI’s recommendation, which would have provided support for the effectiveness for the use of the claimed compounds in treating pain-associated disease, pain caused by trauma or pain caused by iatrogenic, medical or dental procedures, as an example. Given the absence of any disclosed data or guiding principle, thus a POSITA would require to perform extensive screening and testing to determine which compounds, if any, are effective against pain by using Visual analog scale, as an example. This level of experimentation is undue. Therefore, the specification does not enable a POSITA to make and use the full scope of the claimed invention without engaging in unreasonable experimentation. Consequently, the lack of enablement of the claimed subject matter at the time of filing, suggest that Applicant did not possess supporting data for the claimed invention.
112 (Written description)
Claims 14-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention recites compound of formula (XIV) and a method of treating pain caused by trauma; or pain caused by iatrogenic, medical or dental procedures, as an example. The specification (page 140-152) describes a method of treating pain that involves administering a compound through various routes, dosages, and regimens tailored to patient in need therefore. However, the specification fails to provide detailed description of how pain is measured before or after treatment, no clinical assessment of patient response or treatment efficacy, and no mention of clinical or patient-reported outcomes. The specification does not disclose whether the same dosage, route administration, or formulation would apply uniformly across the various types pain listed or claimed compound. Therefore, without an adequate written description linking the claimed compounds to pain management, a POSITA would not reasonably conclude that the inventor has developed or possessed the claimed method. The specification’s failures to disclose adequate details, further supports the conclusion that the specification lacks adequate written description of the claimed subject matter.
Allowable Subject Matter
Claim 8 has been examined and is found to be free of the art of record. The closest prior art is Badolato et al. (RSC Adv). 2018 Jun 7;8(37):20894-20921. While Badolato teaches various 2,3-Dihydroquinazolin-4(1H)-one resembling the claimed invention, however Badolato does not teach any compounds similar to the claimed compound. It is also noted that claim 8 is free of prior art, as are claims 9-11, 13, 31 and 32 which are dependent on claim 8.
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 PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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, JAMES H ALSTRUM-ACEVEDO can be reached on (571) 272-5548. 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.
/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622