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 .
Priority
This application, filed 21 October, 2022, is a national stage application of PCT/JP2021/016372, filed 22 April, 2021, which claims foreign benefit of application JP 2020-174820, filed 16 October, 2020, and JP 2020-076370, filed 22 April, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 28 December, 2022 is acknowledged and has been considered.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 19 January, 2023, in the matter of Application N° 18/145,127. Said documents have been entered on the record.
Claim 11 is new. No new matter was introduced.
Thus, Claims 1-11 represent all claims currently under consideration.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to 5-ALA which is a common precursor of heme compounds produced in the mitochondria in cells (Claims 1-2), and a metal-containing compound such as iron (Claims 3-6), without significantly more.
This judicial exception is not integrated into a practical application because the claims merely recite a product with an intended use comprising naturally occurring components without any additional elements or modifications that impose a meaningful limit on the scope of the claim or result in more than the natural properties of the components themselves.
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.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tanaka et al. (US Patent 9,351,949 B2, published 31 May, 2016), hereinafter Tanaka.
This Patent has a common inventor with the instant application.
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Regarding Claims 1-6, Tanaka (2016) teaches a prophylactic and/or therapeutic agent for influenza viral infection comprising a compound represented by the following formula (I), shown to the right, or a salt thereof, wherein R1 and R2 each represent a hydrogen atom, further comprising an iron compound (‘949, Col 2, Lines 50-67 and Col 3, Lines 1-3.)
The instantly claimed distinction of use “a therapeutic and/or preventative agent for coronavirus disease 2019 (COVID-19)” is merely an intended use that does not confer patentable distinction over the agent disclosed in the patent which also cites intended use as an antiviral: “a prophylactic and/or therapeutic agent for influenza viral infection.”
As such, Claims 1-6 are anticipated.
Claims 1, and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kitajima et al. (Scientific Reports | (2019) 9:8666, published 17 June, 2019, cited in IDS), hereinafter Kitajima.
Regarding Claims 1, and 7-9, Kitajima teaches the combination of 5-ALA (as in instant Claim 1) and the dynamin inhibitor myristyl trimethyl ammonium bromide (MiTMAB) (2019, Pg. 3, § PpIX accumulation in cancer cells after incubation with 5-ALA and a dynamin inhibitor.)
Regarding Claims 7-10, Kitajima teaches the combination of 5-ALA and the ABCG2 inhibitor Fumitremorgin C (FTC) (2019, Pg. 3, § PpIX accumulation in JFCR39 cells after incubation with ALA with or without FTC and dynamin inhibitor.)
As such, Claims 7-10, which depend from Claim 1, are anticipated.
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.
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Tanaka et al. (US Patent 9,351,949 B2, published 31 May, 2016), hereinafter Tanaka, in view of Beigal et al. (Antiviral Research 167 (2019) 45-67, Published 8 April, 2019), hereinafter Beigel, and Wang et al. (Cell Research. 2020. 30:269-271. Published 4 February, 2020, Cited in IDS), hereinafter Wang.
The US Patent 9,351,949 has a common inventor with the instant application.
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Tanaka teaches a prophylactic and/or therapeutic method for influenza viral infection, comprising administering to a subject a compound represented by the following formula (I), shown to the right, or salt thereof (‘949, Col 3, Lines 41-43), which is 5-ALA or its derivatives.
Tanaka fails to teach a prophylactic and/or therapeutic method for coronavirus disease 2019 (COVID-19), “a novel pneumonia caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)” (instant Specification, Pg. 1, Para 2.)
However, Beigel teaches that Influenza and other acute respiratory viral diseases are of major global public health importance. The emergence of high morbidity viruses such as severe acute respiratory syndrome coronavirus (SARS-CoV) in 2004, influenza A(H5N1) in 2005, Middle East respiratory syndrome corona virus (MERS-CoV) in 2012, and influenza A(H7N9) in 2013, as well as discovery of novel viral pathogens such as human metapneumovirus in 2001 and human bocavirus in 2005 have highlighted the importance of international collaboration on respiratory virus research for their prevention and control (2019, Background.) Furthermore, Beigel discloses Remdesivir has both prophylactic and therapeutic effectiveness for SARS- and MERS-CoV in multiple animal models. Pharmacokinetic studies have already been completed and clinical trials were underway for remdesivir to treat Ebola virus (2019, Pg. 56, Col 2, Para 2.)
Wang teaches that in December 2019, a novel pneumonia caused by a previously unknown pathogen emerged. With no specific treatment, effective antiviral agents were urgently needed. Wang discloses that an efficient approach to drug discovery is to test whether the existing antiviral drugs are effective in treating related viral infections. For instance, Wang evaluated the antiviral efficiency of five FAD-approved drugs including chloroquine and remdesivir against a clinical isolate of 2019-nCoV in vitro.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to apply the method of Tanaka – preventing or treating influenza viral infection using 5-ALA and its derivatives – to the treatment of the newly emerging virus disclosed in Wang, in view of the teachings of Beigel and Wang, which together establish that it is routine and scientifically motivated to evaluate known antiviral compounds for activity against newly identified or related viruses, especially in the context of acute respiratory viral diseases with no known therapies. Wang explicitly teaches that repurposing existing antivirals was a prioritized and efficient strategy in response to the emergence of coronavirus disease 2019 (COVID-19), and Beigel provides precedent for evaluating antivirals like Remdesivir for new viral targets. Accordingly, one would have had a reasonable expectation of success in applying 5-ALA – previously demonstrated as effective against influenza viral infection – to the treatment of a novel respiratory virus such as SARS-CoV-2, particularly given the urgent unmet medical need.
Communication
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/D.M.N./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627