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 13 November, 2025 (which replaced the incomplete IDS submitted 12 November, 2025) is acknowledged and has been considered.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 12 November, 2025, in the matter of Application N° 17/920,703. Said documents have been entered on the record.
Claims 1-10 are canceled. Claim 11 is amended. Claims 12-20 are new. No new matter was introduced.
Thus, Claims 11-20 represent all claims currently under consideration.
Response to Arguments
Claims 1-10 have been canceled. Therefore, the rejections of these claims under 35 U.S.C. 101 and 102(a)(1) are moot.
Applicant's arguments filed 12 November, 2025, as well as the supplemental remarks filed 2 December, 2025, have been fully considered but they are not persuasive. The accompanying documents filed with the supplemental remarks on 2 December, 2025, which were submitted outside of an Information Disclosure Statement, while acknowledged are not considered as prior art or evidence of record.
Applicant argues that the rejection of Claim 11 under 35 U.S.C. 103 fails because none of the exemplary rationales set forth in MPEP § 2143 are alleged to apply (Remarks, 12 November, 2025, Pg. 6-7.) This argument is not persuasive. The rationales described therein are illustrative, not exhaustive, and an obviousness rejection is proper where, as here, the prior art provides an articulated reasoning with a rational underpinning in accordance with KSR Int’l Co. v Teleflex Inc. As set forth in the rejection, Tanaka teaches the same compound for antiviral treatment, and Beigel and Wang provide motivation and a reasonable expectation of success for repurposing known antiviral agents to treat newly emerging viral diseases, especially in light of pandemic conditions.
Applicant asserts that the compound disclosed in Tanaka lacks a history as an antiviral, has not received pharmaceutical approval, and has not been placed into practical use, and therefore represents merely one of many speculative possibilities (Remarks, 12 November, 2025, Pg. 7.) These arguments are unavailing. Regulatory approval or commercial adoption is not required for a reference to be relevant to an obviousness determination. Tanaka expressly teaches the use of the same compound for the treatment of influenza, a viral respiratory disease, thereby establishing antiviral use of the compound. The fact that compound had not previously been evaluated against SARS-CoV-2 does not negate the teachings of Tanaka or render the claimed method nonobvious.
Applicant further argues that the effectiveness of the compound against COVID-19 was unpredictable and that Beigel and Wang describe a vast number of screening possibilities requiring excessive trial and error (Remarks, 12 November, 2025, Pg. 7.) This characterization misrepresents the teachings of the prior art. Beigel teaches that evaluation of known antiviral agents against newly emerging viral pathogens is a routine and predictable practice in the art. Wang further teaches that, in response to the COVID-19 pandemic, repurposing existing antiviral compounds was a recognized and prioritized strategy. These references do not advocate indiscriminate searching, but rather targeted evaluation of known compounds with established antiviral activity. Routine screening of such compounds for activity against a new viral target does not constitute undue experimentation and supports a reasonable expectation of success.
Applicant’s reliance on materials published after the effective filing date of the instant application to establish the state of the art is also not persuasive (Supplemental Remarks, filed 2 December, 2025.) Documents published after the effective filing date (22 April, 2020) do not reflect the state of the art at the time of the invention and are not relevant to the determination of obviousness.
As such, the rejection under 35 U.S.C. 103 is maintained for the reasons previously set forth, as modified below in view of Applicant’s amendments, in addition to new rejections based on amendments.
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 11-20 is 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.
Claim 11 recites “comprising: administering a therapeutic and/or preventive agent comprising a compound or a salt of the compound,” and further defines substituents groups R1 and R2, ending with the phrase “with a pharmaceutically acceptable excipient to a subject.” It is unclear what the phrase “with a pharmaceutically acceptable excipient” modifies. In particular, it is unclear whether the excipient is associated with the substituent R2, the compound of Formula I, the therapeutic agent, or the act of administration. Because a substituent cannot itself be combined with a pharmaceutically acceptable excipient, and because the claim does not clearly recite whether a compound per se or a pharmaceutical composition is being administered, the scope of the claimed method is uncertain.
Claim 12 recites “wherein R1 and R2 are respectively a hydrogen atom.” The term “respectively” is used without corresponding distinct values for R1 and R2, rendering it unclear whether each of R1 and R2 is hydrogen or whether a different relationship is intended.
Claim 13 recites “further comprising one or more metal-containing compounds” without specifying how such compounds are used in the claimed methods. In particular, it is unclear whether the metal-containing compounds are administered to the subject, co-administered with the compound of Formula I, or otherwise involved in the method. Because the claim does not clearly recite an additional method step or define the role of the metal-containing compounds, the scope of the claim is uncertain.
Claim 17 recites “wherein the therapeutic and/or preventive agent is used in combination with a PPIX release inhibitor” without specifying how the PPIX release inhibitor is employed in the claimed method. In particular, it is unclear whether the PPIX release inhibitor is administered to the subject, co-administered with the therapeutic agent, or otherwise involved in the method. Because the claim does not clearly recite a method step involving the PPIX release inhibitor, the scope of the claimed method is uncertain.
Claims 14-16 and 18-20 are dependent on Claims above, and fail to cure their deficiencies.
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.
Claims 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka (US Patent 9,351,949 B2, of previous record), in view of Beigal (Antiviral Research 167 (2019) 45-67, of previous record), and Wang (Cell Research. 2020. 30:269-271, of previous record).
The US Patent 9,351,949 has a common inventor with the instant application.
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Regarding Claims 11-16, Tanaka (2016) teaches a prophylactic and/or therapeutic agent for influenza viral infection comprising administering 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, Col 3, Lines 1-3, and Lines 41-45.)
Although Tanaka does not explicitly use the term “excipient,” it discloses the addition of “pharmacologically acceptable carrier, filler, diluent, additive, disintegrator, binder, coating, lubricant, slipping agent, lubricating agent, flavoring agent, sweetener, solubilizer, solvent, gelling agent, nutrient and the like” (‘949, Col 8, Lines 59-63), which are collectively recognized in the art as excipients.
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.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka, Beigel, and Wang, applied to Claims 11-16 above, and further in view of Kitajima (Scientific Reports | (2019) 9:8666, of previous record.)
The teachings of Tanaka, Beigel, and Wang are set forth in the above 35 U.S.C. 103 Rejections and are incorporated herein. Tanaka, Beigel, and Wang teach a therapeutic and/or preventive treatment of COVID-19, comprising administering a compound represented by the following formula (I), in which 5-ALA is embodied, with a pharmaceutically acceptable excipient to a subject.
Regarding Claims 17-19, Kitajima teaches the combination of 5-ALA 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 17-20, 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.)
Therefore, as Kitajima teaches co-administration of a compound of Formula I in combination with the PPIX release inhibitors, thereby demonstrating that such combinations were known, feasible, and used in therapeutic methods, 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 combine 5-ALA in a method of treating Covid-19, as taught by Tanaka, Beigel, and Wang with PPIX release inhibitors, as demonstrated by Kitajima, a reasonable expectation of success.
Conclusion
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.
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/D.M.N./Examiner, Art Unit 1627 /SARAH PIHONAK/Primary Examiner, Art Unit 1627
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