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 .
Status of Claims
Claims 1-20 are pending.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C.
120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to
Application Serial No. PCT/US2020/043178, filed 07/23/2020. The application also claims priority to
PRO application number 62/878,012, filed on 07/24/2019.
Information Disclosure Statement
All references from IDS(s) received 11/21/2022 have been considered unless marked with a strikethrough.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vatansever, E. et al. (BioRxviv doi: https://doi.org/10.1101/2020.05.23.112235, published 5/23/2020; “Vatansever”).
Vatansever teaches a study of different small molecule anti-virals for the treatment of SARS-COV-2 (or COVID-19), including bepridil (Abstract). Vatansever also suggests further considerations of using bepridil in COVID-19 clinical tests.
Therefore instant claims 1-2 are anticipated by Vatansever.
Claims 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dewald et al(J Infect Dis. 2018 Nov 22;218(suppl_5):S588-S591.; “Dewald).
Dewald teaches a method of treating a viral infection with Bepridil. Dewald also teaches the use of Bepridil for the use in prevention or “prophylactically treating” (see excerpt below), as required by instant claims 11-12.
“No vaccines or therapeutics are currently approved for use to prevent or treat disease caused by these viruses. A screen of United States- and ex-United States-approved drugs identified the calcium channel blocker, bepridil, as an active inhibitor of multiple filoviruses, including Ebola virus (EBOV), Sudan virus (SUDV), Marburg virus (MARV), and Ravn virus in tissue culture. Bepridil inhibits EBOV at a late stage of viral entry, possibly by binding to the viral glycoprotein (GP) and preventing fusion with the endosomal membrane” (Introduction).
Therefore instant claims 11-12 are anticipated by Dewald.
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 7, 9-10, 11-15, 18, and 20 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hsu, T. et al. (US7544712B1; cited in IDS filed 11/21/2022; “Hsu”).
Hsu teaches a method for treating, where treating includes preventing (detailed description 3rd paragraph), coronavirus infection with an effective amount of one or more of a list of compounds including bepridil and trifluoperazine (Abstract), as required by instant claims 1-4, 7, 11-15 and 18. Hsu also teaches the compounds can be administered orally or intravenously (through injection) (detailed description 4th paragraph), as required by instant claims 9-10 and 20. This rejection is based on the idea that a person skilled in the art could envisage the compounds bepridil or trifluoperazine from the list in the art.
In the alternative, Hsu teaches a list with a finite number of compounds, but Hsu fails to explicitly teach an embodiment including bepridil or trifluoperazine. However, it would have been obvious to a person skilled in the art at the time to choose a compound from the list to treat/prevent coronavirus.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement
to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a
reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same
field or a different one based on design incentives or other market forces if the variations are
predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of
ordinary skill to modify the prior art reference or to combine prior art reference teachings to
arrive at the claimed invention.
Applying KSR example rationale (E), it would have been prima facie obvious to try a compound, such as bepridil or trifluoperazine, from the finite list of compounds taught by Hsu for the treatment/prevention of coronavirus. A person skilled in the art would have been motivated to do so because these compounds are some of only a few from a finite list taught to treat coronavirus. Therefore, claims 1-4, 7, 9-10, 11-15, 18, and 20 would have been obvious to a person skilled in the art at the time.
Claim Rejections - 35 USC § 103
Claims 1-4, 7-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Malaknov et al. (US20070190163; cited in IDS filed 11/21/2022; “Malaknov”) as evidenced by World Health Org. EMR (https://www.emro.who.int/health-topics/severe-acute-respiratory-syndrome/; “WHO”) and Coronaviridae Study Group of the International Committee on Taxonomy of Viruses (Nat Microbiol. 2020 Mar 2;5(4):536–544. doi: 10.1038/s41564-020-0695-z; “CSG”).
Malaknov teaches a method of developing a composition to treat diseases including to treat infectious disease such as SARS (p. 0466). This composition may include antianginals such as bepridil (p. 0223) and phenothiazines such as trifluoperazine (p. 0339), as required by instant claims 1-3 and 11-13. Malaknov also teaches the compounds may be used in combination (p.0468) and may be used in oral or intravenous administration (p. 0469), as required by instant claims 4, 7, 9-10, 14-15, 18, and 20. One of the compounds/active ingredients may be an anti-inflammatory drug (Claim 52), as required by instant claims 8 and 19.
Malaknov fails to explicitly teach SARS-CoV-2, however, does teach the treatment of SARS. SARS (Severe Acute Respiratory Syndrome) is a viral respiratory illness caused by the SARS-associated coronavirus (SARS-CoV), as evidenced by WHO. Among SARS/SARS-CoV genus there is a very limited amount of specific species, one of which is SARS-CoV-2, as evidenced by CSG. Since SARS-CoV-2 is within the SARS family of viruses, it would have been obvious to a person skilled in the art that the compounds could be used in the treatment of SARS-CoV-2.
Applying KSR example rationale (G), it would have been prima facie obvious to extract the method of treating a SARS infection with bepridil or trifluoperazine, or a mixture of both, including other active agents such as an anti-inflammatory, as taught by Malaknov, and treat SARS-CoV-2. A person skilled in the art would have been motivated to do so because SARS-CoV-2 is one of only a few species that belongs to the family of SARS infections, as evidenced by CSG. Therefore, claims 1-4, 7-15, and 18-20 would have been obvious to a person skilled in the art at the time.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Malaknov et al. (US20070190163; “Malaknov”) in view of Vatansever, E. et al. (BioRxviv doi: https://doi.org/10.1101/2020.05.23.112235, published 5/23/2020; “Vatansever”).
Malaknov teaches the limitations of claims 1-4, 7-15, and 18-20. Malakanov fails to teach the use of Remdesivir, as required by instant claims 5-6 and 16-17.
Malaknov does teach that the composition can include other active agents including other antivirals (p. 0114).
Vatansever teaches bepridil for use in treating SARS-CoV-2. Vatansever also teaches that remdesivir was chosen as a viable chouse for the treatment of COVID-19 and was approved for emergency use in the United States and Japan (Introduction). Although Vatansever does not explicitly teach the combinatorial use of Remdesivir with other antivirals, it would be obvious through the teachings of Malaknov to use another antiviral, such as one with well-recognized effects like Remdesivir, as taught by Vatansever, in the mixture with bepridil or trifluoperazine.
Applying KSR example rationale (A), it would have been prima facie obvious to extract the method of treating a SARS infection with bepridil or trifluoperazine, or a mixture of both, including other active agents such as other anti-virals, as taught by Malaknov, and include Remdesivir as the second antiviral. A person skilled in the art would have been motivated to do so because Remdesivir is a well-recognized drug for use in the treatment of SARS-CoV-2 and other infections, as taught by Vatansever. Therefore, claims 1-20 would have been obvious to a person skilled in the art at the time.
Conclusion
Claims 1-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621