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 .
Priority
This application is a 371 of PCT/KR2021/007104 (06/08/2021) and claims foreign priority to KOREA, REPUBLIC OF 10-2020-0069697 (06/09/2020).
Status
Claims 1-11 are pending.
Regarding prior art rejections, Applicant amended the claims by deleting alternatives in a manner that avoids the prior art rejections. These rejections are withdrawn.
Regarding enablement rejections, Applicant argues that the level of skill is high such that the POSITA in the field of drug discovery employing routine efforts on a specific compound would arrive at the claimed invention without “effectively zero” or undue experimentation. This argument is persuasive as to the current scope of the claims and the rejection withdrawn.
New Claim Rejections - 35 USC § 102
Claims 1, 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Orenstein (“Gastroenteritis, Viral”, Encyclopedia of Gastroenterology (Second Edition), Academic Press, 2020, Pages 652-657, Available online 1 November 2019).
Orenstein teaches administration of diphenoxylate for treating the viral infection, viral gastroenteritis (Title, p. 656).
Claims 1, 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gastaminza et al. (WO2010101649).
Gastaminza teaches administration of diphenoxylate for treating the viral infection, HCV (Abstract; claims 15, 25).
New Claim Rejections - 35 USC § 103
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (Acta Pharmaceutica Sinica B 2020;10(5):766-788) in view of Gastaminza et al. (WO2010101649) and Orenstein (“Gastroenteritis, Viral”, Encyclopedia of Gastroenterology (Second Edition), Academic Press, 2020, Pages 652-657, Available online 1 November 2019).
Wu proposes diphenoxylate for treating SARS-CoV-2 (Table 5).
Wu does not provide a specifically teach treatment of a patient.
Gastaminza teaches administration of diphenoxylate for treating the viral infection, HCV (Abstract; claims 15, 25). Orenstein teaches administration of diphenoxylate for treating the viral infection, viral gastroenteritis (Title, p. 656).
One of ordinary skill in the art following the teaching of Wu would have considered using diphenoxylate to newer coronavirus, including SARS-CoV-2, because the reference specifically suggests it. One of ordinary skill in the art would have had a reasonable expectation of success in view of the secondary references because the agent was already known to teach viral infections. Thus, it was prima facie obvious to use the pharmaceutical as suggested on a novel disease in view of prior successful use in other viral diseases and arrive at the claimed invention.
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (Acta Pharmaceutica Sinica B 2020;10(5):766-788) in view of Gastaminza et al. (WO2010101649) and Orenstein (“Gastroenteritis, Viral”, Encyclopedia of Gastroenterology (Second Edition), Academic Press, 2020, Pages 652-657, Available online 1 November 2019) as applied to claims 1-7 above and further in view of Lengerich (US 20070141096).
Wu does not teach the pharmaceutical as a food composition.
Lengerich teaches diphenoxylate as a food composition (claims 25, 28, 147-148).
The level of skill in the art is very high such that one of ordinary skill in the art would have considered routine the optimization of a formulation of a pharmaceutical shown to be effective in feasible formulations and routes of administration including IV, tablets, and food – all of which were well-known and routinely used in the art. Thus, one of ordinary skill in the art would have readily considered including the pharmaceutical in a food composition to treat the same viral infection and arrive at the claimed invention with a reasonable expectation of success.
With each of the above claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combined teachings of the art. Through the combined teachings, one of ordinary skill in the art would have arrived at the invention as claimed with a reasonable expectation of success before the effective filing date of the claimed invention.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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, Kortney Klinkel can be reached at (571) 270-5293. 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.
/ROBERT H HAVLIN/ Primary Patent Examiner, Art Unit 1626
Prosecution Insights