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 application is a national stage application of PCT/KR2022/002329, filed February 17, 2022, which claims priority to foreign application KR-10-2021-0026365, filed February 26, 2021. Claims 1-9 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted August 9, 2023, is acknowledged wherein claims 1-9 are amended.
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 6-9 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. Independent claim 6 is directed to a method of treating a subject comprising administering to the subject a carbocyclic nucleoside derivative having a specific formula. However the actual structure of the carbocyclic nucleoside
PNG
media_image1.png
101
102
media_image1.png
Greyscale
which is not carbocyclic. Furthermore the base moiety B is defined as a purine structure which is also not carbocyclic. Given the contradiction between the description of the compound and the asserted structure it is unclear what structure is actually required by the claimed method, rendering the claims indefinite.
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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon et al. (Reference included with PTO-1449) in view of Elmessaoudi-Idrissi et al. (Reference included with PTO-892)
Claim 1 is directed to a method of preventing or treating coronavirus disease 19 (COVID-19) comprising administering to a subject in need thereof a particular carbocyclic nucleoside. Dependent claim 2 further defines the structure of said compound as having a particular mono-fluoro structure. Dependent claims 4 and 5.
Yoon et al. discloses the synthesis of 6’- mono- or di- fluoro derivatives of the nucleoside analog (-)-Aristeromycin. (p. 6437 right column second and third paragraphs) These derivatives include compounds 2a-2e which as fluorinated carbocyclic derivatives according to formulae A-1, 1-1, and 1-2 recited in present claims 1-3. (p. 6349 scheme 4) These compounds were tested against several RNA viruses including the coronaviruses SARS-CoV and MERS-CoV. (p. 6350 right column last paragraph – p. 6351 right column first paragraph) These compounds were found to possess antiviral activities and to be promising as therapeutic agents for the treatment of these viral infections. (p. 6351 right column last paragraph – p. 6351 left column first paragraph, p. 6351 left column first paragraph) Yoon et al. dopes not specifically describe a method wherein the viral infection is coronavirus disease 19, caused by the infectious agent SARS-CoV2.
Elmessaoudi-Idrissi et al. discloses that there is a need for new small molecule drugs active against SARS-COV2, the causative agent for COVID-19. (p. 549 right column last paragraph – p. 550 left column first paragraph) The reference furthermore describes a screen of a library of compounds against molecular targets form the proteome of SARS-CoV2. (p. 550 left column last paragraph – right column third paragraph) One of the promising compounds identified was 6’-fluoroaristeromycin, which is compound 2a or 2b according to Yoon et al. (p. 551 left column last paragraph) This compound was further reported to bind to S-adenosylhomocysteine hydrolase, which is one of the molecular targets identified by Yoon et al. for this compound.
It would have been obvious to one of ordinary skill in the art at the time of the invention to administer these drugs to a subject suffering from COVID-19 disease caused by SARS-CoV2. One of ordinary skill in the art would have seen this to be obvious based on the disclosure by Yoon et al. that these compounds are promising antiviral agents against several closely related viruses, and further suggested by the disclosure by Elmessaoudi-Idrissi et al. that one of said compounds is additionally effective against SARS-CoV2 SAH hydrolase.
Regarding claims 4 and 5, these claims define particular numerical values for properties of the claimed compound in treating SARS-CoV2. It is reasonably expected that these properties are necessarily associated with a particular chemical structure and would therefore have been necessarily present for any method using the same claimed compound. In particular, table 1 on p. 26 of the present specification discloses that a compound of chemical formula 1-1 (6’-fluoroaristeromycin) possesses values for IC50, CC50, and SI as recited in claim 4 and chemical formula 1-2 (6’,6’-difluoroaristeromycin) possesses values as recited in claims 5 and 5.
For these reasons the invention taken as a whole is prima facie obvious.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREA OLSON whose telephone number is (571)272-9051. The examiner can normally be reached M-F 6am-3:00pm.
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, Scarlett Y Goon can be reached at 571-270-5241. 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.
/ANDREA OLSON/ Primary Examiner, Art Unit 1693 12/15/2025
Prosecution Insights