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 20 September, 2022, is a national stage application of PCT/US2021/057123, filed 19 March, 2019, which claims benefit of foreign priority Application N° EP20306483.7, filed 3 December, 2020, Application N° EP20305482.0, filed 12 May, 2020, Application N° EP20305327.7, 25 March, 2020, and Application N° EP20305299.8, filed 20 March, 2020.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 4 September, 2025, in the matter of Application N° 17/913,063. Said documents have been entered on the record.
Claims 23-24, 33, 38, and 41 are amended. Claims 27-28 are canceled. Claims 44-45 are new. No new matter was introduced.
Thus, Claims 23-26, and 29-45 represent all claims currently under consideration.
Response to Amendments/Arguments
Applicant’s amendments and cancellations are sufficient to overcome the previous rejections filed 5 June, 2025, under 35 U.S.C. §§112(b), and 102(a)(1).
Applicant's arguments filed 4 September, 2025, have been fully considered but they are not persuasive. While Applicant has amended select claims to recite “wherein the Coronaviridae is an Alphacoronavirus or a Betacoronavirus or a Deltacoronavirus or a Gammacoronavirus” and has argued “a therapeutic effect of ABX464 on COVID-19 patients would have been entirely unexpected” (Arguments, Pg. 8), the cited references collectively and individually render the claims unpatentable. As explained below, the prior art of record continues to provide obviousness grounds, and therefore are maintained and, where necessary by amendment, are restated using the same references.
Use against coronavirus infections: Garcel expressly discloses the instant compounds for treatment of viral infections, including coronaviruses. Mahuteau-Betzer teaches both the methylated species and a genus encompassing (the non-methylated version) ABX464 for treatment of RNA viruses, and explicitly names SARS viruses, which is a Betacoronavirus within Coronaviridae. Therefore, Applicant’s argument that Coronaviridae is never mentioned in Mahuteau-Betzer (Arguments, Pg. 9) is unpersuasive, as SARS is a canonical member of this family, well recognized prior to the effective filing date.
Compound identity: Applicant’s argument that Mahuteau-Betzer and Najman disclose different compounds (Arguments, Pg. 10) is also not persuasive. Mahuteau-Betzer’s genus encompasses ABX464, and Najman explicitly teaches Compound 1 (‘892, Pg. 26, Line 5) which is ABX464.
Effects of miR-124 on DMN2: Najman discloses miR-124 is validated as being a relevant biomarker to monitor the efficacy of quinoline derivatives (to include ABX464) as anti-viral drugs, albeit in the context of HIV. Yang independently discloses the effects of miR-124 on DMN2 for another Group IV virus. Therefore, Applicant’s assertion that the pathway disclosure is limited to HIV (Arguments, Pg. 11) is not persuasive. A person of ordinary skill in the art would have reasonably expected applicability across related +ssRNA viruses, including coronaviruses, particularly where Yang demonstrates the same pathway in a different Group IV virus.
Unexpected Results: Applicant argues that the observed impact of miR-124 on DMN2 in relation to Coronaviridae infections is surprising and significant (Arguments, Pg. 8-9.) However, where the prior art already teaches the same compounds, the same miR-124 to DMN2 targeting, and the same viral family, the alleged results are inherent to the disclosed use and do not confer patentability.
COVID-19 novelty: The fact that SARS-CoV-2 was a newly emergent pathogen at the effective filing date does not render its treatment nonobvious. The prior art teaches use of the claimed compounds for coronaviruses broadly (Garcel) and for SARS specifically (Mahuteau-Betzer.) Moreover, as of 20 March, 2020, the global COVID-19 pandemic presented an urgent, widely recognized need for coronavirus therapeutics, which would have strongly motivated a person of ordinary skill in the art to apply known antiviral compounds already taught for coronaviruses and Group IV viruses, with a reasonable expectation of success.
Accordingly, the prior 35 USC § 103 and Non-statutory Double Patent rejections are maintained, and where necessary restated to account for Applicant’s amendments. The same references of record (Garcel, Mahuteau-Betzer, Najman, and Yang) are relied upon because they remain the most pertinent prior art, disclosing (i) the instant compounds, (ii) their use against coronaviruses including SARS, and (iii) the same miRNA-124/DNM2 dynamic in connection with viral infections in Group IV viruses. Applicant’s amendments do not overcome these teachings.
Additionally, below can be found new grounds of rejection necessitated by amendments.
Claim Rejections - 35 USC § 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 23-26, 36-37, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Garcel (EP 3058940 A1, of previous record.)
Reference shares two Inventors and Assignee with the instant application.
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Regarding Claims 23-24, Garcel teaches quinoline derivatives of Formula (I), shown top right, or anyone of its pharmaceutically acceptable salt, or anyone of its metabolites, for use for treating or preventing a viral infection (‘940, Pg. 1 Abstract), to include coronaviruses (‘940, Pg. 6, Para 0059.) Garcel exemplifies compounds of Formula I, such as compound 22 (‘940, Pg. 16, Table A, Compound 22), shown middle right, and its N-glucuronide metabolite (‘940, Pg. 8, Para 0074), shown bottom right.
Regarding Claims 25-26, Garcel teaches suitable physiologically acceptable acid addition salts of compounds of formula (I) include hydrobromide, tartrate, citrate, trifluoroacetate, ascorbate, hydrochloride, triflate, maleate, mesylate, formate, acetate and fumarate (‘940, Pg. 13, Para 0127.)
Regarding Claim 36, Garcel teaches a compound according to the present invention may be implemented within pharmaceutical composition that may contain an effective amount of said compound, and one or more pharmaceutical excipients (‘940, Pg. 23, Para 0213.)
Regarding Claim 37, Garcel teaches a compound of formula (I) can be administered by oral, parenteral, intravenous, transdermal, intramuscular, rectal, sublingual, mucosal, nasal, or other means (‘940, Pg. 23, Para 0216.)
Regarding Claim 43, Garcel teaches the present invention has for purpose to lower a viral load in a patient infected by a virus (‘940, Pg. 2, Para 0001.)
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 use the known instant compounds, their salts, and compositions thereof for the treatment of coronavirus infection, because Garcel explicitly discloses administration of these same compounds for treatment of viral infections, including coronaviruses. A person or ordinary skill in the art would have been further motivated at the March 2020 effective filing date by the urgent and globally recognized public health crisis created by the COVID-19 pandemic to investigate known antiviral compounds already disclosed for use against coronaviruses, with the goal of reducing viral load. One would have had a reasonable expectation of success that such administration would reduce coronavirus viral load, because Garcel teaches the antiviral effectiveness of the compounds broadly, and specifically identifies coronavirus among treatable viral infections.
Claims 23, 25-26, 29-32, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Mahuteau-Betzer (WO 2020011810 A1, of previous record.) MAINTAINED
Reference shares three Inventors and Assignee with the instant application.
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Regarding Claims 23 and 25, Mahuteau-Betzer teaches Compound 1 (‘810, Pg. 39, Table 1, Compound 1), shown top right, or any of its pharmaceutically acceptable salts, for use in the treatment and/or prevention of an RNA virus infection caused by an RNA virus belonging to group IV of the Baltimore classification, which includes +ssRNA viruses such as Coronaviridae. Compound 1 differs from the instantly claimed Formula I compound by a single methyl substitution off the phenyl ring. However, Mahuteau-Betzer teaches the genus Formula I (‘810, Pg. 8, Lines 12-14), shown bottom right, wherein R2 can be H, as in the instantly claimed Formula I.
Regarding Claim 26, Mahuteau-Betzer teaches pharmaceutically acceptable salts, such as hydrobromide, tartrate, citrate, trifluoroacetate, ascorbate, hydrochloride, tosylate, triflate, maleate, mesylate, formate, acetate and fumarate (‘810, Pg. 31, Lines 25-26.)
Regarding Claims 29-32, Mahuteau-Betzer teaches viruses pertaining to group IV can be SARS virus (‘810, Pg. 2, Line 25.) The taxonomy of SARS virus is known in the art as Coronaviridae (Family), Orthocoronavirinae (Subfamily), Betacoronavirus (Genus), Sarbecovirus (Subgenus), and Severe Acute Respiratory Syndrome-related Coronavirus (Species). The SARS virus classification includes both SARS-CoV(2002) and SARS-CoV-2 (COVID-19 virus) which belong to the same species.
Regarding Claim 36, Mahuteau-Betzer teaches pharmaceutical composition comprising at least one new compound as defined or any of its pharmaceutically acceptable salts, and also at least one pharmaceutically acceptable excipient (‘810, Pg. 79, Lines 8-13.)
Regarding Claim 37, Mahuteau-Betzer teaches compositions of this invention may be administered in any manner, including, but not limited to, orally, parenterally, sublingually, transdermally, vaginally, rectally, transmucosally, topically, intranasally via inhalation, via buccal or intranasal administration, or combinations thereof (‘810, Pg. 81, Lines 20-23.)
It would have been prima facie obvious to use the non-methylated species of ABX464, or its pharmaceutically acceptable salts and compositions, for the treatment of coronavirus infection, because Mahuteau-Betzer discloses the methylated species and a genus expressly encompassing both methylated and non-methylated forms for treatment of RNA viruses, including SARS virus, which is a Betacoronavirus within Coronaviridae. A person of ordinary skill in the art would have been motivated to select the non-methylated compound from the disclosed genus in view of the explicit teaching that the compounds are useful against Group IV RNA viruses and specifically against SARS, a member of the claimed viral family. One would have had a reasonable expectation of success because the structural modification involves a conservative change within a well-understood framework, consistent with routine optimization.
Claims 23, 34-35, 37-41 are rejected under 35 U.S.C. 103 as being unpatentable over Najman (WO 2014/111892 Al, of previous record and incorporated as reference in instant disclosure), and further in view of Mahuteau-Betzer (WO 2020011810 A1, of previous record) and Yang (Virology Journal. 2016. 13:105 DOI 10.1186/s12985-016-0562-y, of previous record). MAINTAINED
Reference shares two Inventors and Assignee with the instant application.
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Regarding Claim 23, Najman teaches a use of at least one miRNA, said at least one miRNA being miR-124, as a biomarker of a viral infection, or of an efficacy of a therapeutic treatment of said viral infection (‘892, Pg. 4, Lines 19-21), wherein a therapeutic treatment of said viral infection can be a treatment with quinoline derivatives (‘892, Pg. 4, Lines 31-32), wherein a quinoline derivative can be Compound 1 (‘892, Pg. 26, Line 5), shown to the right.
Regarding Claim 34 and 40, Najman teaches a biological sample suitable for the invention may be selected in a group consisting of a biological tissue sample, a whole blood sample, a swab sample, a plasma sample, a serum sample, a saliva sample, a vaginal fluid sample, a sperm sample, a pharyngeal fluid sample, a bronchial fluid sample, a fecal fluid sample, a cerebrospinal fluid sample, a lacrymal fluid sample and a tissue culture supernatant sample (‘892, Pg. 9, Lines 15-19.)
Regarding Claim 35, Najman teaches the invention further relates to an isolated biological sample comprising a biomarker, wherein said biological sample is selected in a group comprising, and preferably consisting in a tissue sample, whole blood, swab sample, plasma, serum, saliva, vaginal fluid, sperm, pharyngeal fluid, bronchial fluid, fecal fluid, cerebrospinal fluid, lacrymal fluid and tissue culture supernatant; wherein said biomarker is a miRNA biomarker, and preferably miR-124 (‘892, Pg. 9, Lines 20-24.)
Regarding Claim 37, Najman teaches any route of administration may be used. For example, a quinoline derivative can be administered by oral, parenteral, intravenous, transdermal, intramuscular, rectal, sublingual, mucosal, nasal, or other means. In addition, a quinoline derivative can be administered in a form of pharmaceutical composition and/or unit dosage form (‘892, Pg. 27, Lines 21-24.)
Regarding Claims 38-39 and 41, Najman teaches a method for assessing the biological effect of a candidate compound and in particular for screening a drug candidate or vaccine candidate, presumed effective in preventing and/or treating a viral infection, comprising at least the steps of:
a- treating at least one isolated cell able to express at least one miRNA, said at least one miRNA being miR-124, with said candidate, said cell being under conditions suitable for expressing said at least one miRNA,
b- measuring a presence or expression level of said at least one miRNA,
c- comparing said measured presence or expression level with a measure or expression level of said at least one miRNA in an untreated isolated cell, wherein a modulated presence or level of expression of said miRNA is indicative of a biological effect of a candidate compound and in particular of the efficacy of said drug candidate or vaccine candidate on a viral infection (‘892, Pg. 9, Lines 25-35 and Pg. 10, Lines 1-3) and that uses and methods of the invention are carried out in vitro or ex vivo (‘892, Pg. 11, Lines 3-4.)
Najman fails to define the virus infection as a Coronaviridae infection.
However, Mahuteau-Betzer teaches the same quinoline derivatives as Najman’s Compound 1, for use in the treatment and/or prevention of an RNA virus infection caused by an RNA virus belonging to group IV of the Baltimore classification, which includes +ssRNA viruses such as Coronaviridae.
Yang further teaches that miR-124 attenuates Japanese encephalitis virus (JEV) replication (Title) and more specifically that over expression of miR-124 inhibits JEV replication (Conclusion.) JEV is a Flavivirus, belonging to the Flaviviridae family. Like Coronaviridae, both belong to group IV of the Baltimore classification.
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 administer the instant compounds of Najman for treatment of coronavirus infection by modulation of the miR-124/DNM2 pathway. One would have been motivated to combine these teachings because Najman discloses the claimed compound and its effect on the miR-124/DNM2 pathway in HIV, Mahuteau-Betzer discloses the same compound genus (including the non-methylated instant species) for treatment of Group IV RNA viruses and explicitly SARS virus, and Yang demonstrates that the identical miR-124/DNM2 pathway is operative in another Group IV virus, thereby linking the host pathway to viral infections beyond HIV and establishing its applicability to coronaviruses to include explicitly SARS virus. One would have had a reasonable expectation of success that the same compounds would modulate the miR-124/DNM2 pathway in coronaviruses to reduce viral load, particularly given that coronaviruses were already disclosed targets in the art and that, at the March 2020 filing date, the urgent global need for coronavirus therapeutics created by the COVID-19 pandemic provided a compelling further motivation to apply known antiviral compounds to the newly emergent SAR-CoV-2.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Garcel (EP 3058940 A1), further in view of August (Veterinary Clinics of North America: Small Animal Practice-Vol. 14, No. 5, September 1984.)
August teaches the inflammatory immune response in FIPV could more accurately be described as feline coronaviral vasculitis (1984, Introduction.) Feline coronavirus is classified in the family Coronaviridae, subfamily Coronavirinae, genus Alphacoronavirus, and species Alphacoronavirus 1. August further discloses coronaviral antibody opsonizes FIPV, enhancing its uptake into macrophages (1984, Pg. 974, §Cell-Associated Viremia), and describes the “vicious cycle of complement-mediated vascular damage”.
August fails to teach the administration of ABX 464.
However, as Garcel teaches quinoline derivatives of Formula (I), to include ABX 464, for use for treating or preventing coronaviruses (‘940, Pg. 6, Para 0059), 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 administer the compounds of Garcel for the treatment of vasculitis associated with coronavirus infection. One would have been motivated to combine these teachings because Garcel discloses the compounds for treatment of coronavirus infections, while August establishes that coronaviruses are capable of inducing vasculitis as part of their inflammatory disease response in mammalian hosts, thereby directly linking coronavirus infection with vascular pathology. One would have had a reasonable expectation of success that administration of the compounds would mitigate coronavirus-associated vasculitis, since the compounds were already taught to be effective antivirals against coronaviruses and vasculitis was a known sequela of coronavirus infection, with the COVID-19 pandemic providing an additional compelling motivation to pursue such treatment.
Claims 44-45 are rejected under 35 U.S.C. 103 as being unpatentable over Li and De Clercq (Nature Reviews Drug Discovery, Vol 19, 2020, posted online 19 February, 2020, Publish March, 2020), further in view of Garcel (EP 3058940 A1, of previous record.)
Li and De Clercq disclose that a study reported that remdesivir inhibited 2019-nCoV, and a US patient with 2019-nCoV recovered after receiving intravenous remdesivir (2020, Pg. 150, Col 1, Para 1.) Furthermore, that “the rapid identification of effective interventions against 2019-nCoV is a major challenge. Given the available knowledge on their safety profiles, and in some cases efficacy against closely related coronaviruses, repurposing existing antiviral agents is a potentially important near-term strategy to tackle 2019-nCoV. Phase III trials of remdesivir have been initiated” (2020, Pg. 150, §Outlook.)
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 administer the compounds of Garcel in combination with Remdesivir for the treatment of coronavirus infection. One would have been motivated to combine these teachings because Garcel discloses antiviral compounds for treating coronavirus infections, while contemporaneous reviews identified Remdesivir as one of the leading antiviral candidates for COVID-19 therapy, making combination approaches with other antivirals an obvious avenue of investigation. One would have had a reasonable expectation of success that combining known antiviral compounds with Remdesivir would reduce coronavirus viral load, particularly given that combination therapy is a routine strategy in antiviral treatment and, at the March 2020 effective filing date, the urgent global demand for COVID-19 therapeutics provided a compelling further motivation to pursue such combinations.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 24 and 36 rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-3, 7-10 of U.S. Patent No. US 10,329,317 in view of Garcel et al. (EP 3058940 A1, published 26 August, 2016, cited in IDS). MAINTAINED
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Patent ‘317 teaches a quinoline derivative of formula (1), shown to the left, or a pharmaceutically acceptable salt thereof (‘317, Claim 1), a pharmaceutical composition comprising the quinoline derivative and at least one pharmaceutically acceptable excipient (‘317, Claim 2), and a medicament comprising the quinoline derivative (‘317, Claim 3.) Further, Patent ‘317 teaches a method for treating or reducing likelihood of occurrence or reoccurrence , of a human immunodeficiency virus (HIV) infection or of acquired immune deficiency (AIDS), comprising administering to a subject a quinoline derivative of formula (1), or a pharmaceutically acceptable salt thereof (‘317, Claims 7-10.)
While Patent ‘317 fails to teach the treatment of Coronaviridae infection and conditions related thereto specifically, and in preferred embodiments focuses on treatment for HIV and AIDS, it does teach the compound of formula 1 can be used in the overall treatment of viral or retroviral infection and virus-related conditions (‘317, Col 2, Lines 25-27.)
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Additionally, Garcel teaches quinoline derivatives of Formula (I), shown top right, or anyone of its pharmaceutically acceptable salt, or anyone of its metabolites, for use for treating or preventing a viral infection, (‘940, Pg. 1 Abstract), to include viruses, and in particular retroviruses such as HIV, and coronaviruses (‘940, Pg. 6, Para 0059.) Garcel exemplifies compounds of Formula I, such as compound 22 (‘940, Pg. 16, Table A, Compound 22), shown middle right, and its N-glucuronide metabolite (‘940, Pg. 8, Para 0074), shown bottom right.
As, Garcel teaches the compound shown bottom right (known as a N-glucuronide metabolite of Compound 22 in Garcel, Formula I in Patent ‘317, and Formula II in the instant application) treats both of the viral infections HIV and coronaviruses, Patent ‘317’s claims for treating HIV, and the instant application claims for treating Coronaviridae, using the same compound are not patentably distinct.
Claims 23, 34-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 3-4, 6-7, 10, and 12-14, of U.S. Patent No. US 11,441,181 in view of Garcel et al. (EP 3058940 A1, published 26 August, 2016, cited in IDS). MAINTAINED
Patent ‘181 teaches an in vitro or ex vivo method of assessing an activity of a quinoline derivative of formula I or a pharmaceutically acceptable salt thereof, for preventing and/or treating a HIV infection in a patient treated with said quinoline derivative, comprising at least the steps of:
Measuring a presence or an expression level of at least one miRNA, including miR-124
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Determining if said expression level of said miRNA is indicative of an activity of said quinoline derivative; wherein formula I is:
(‘181, Claim 3), and wherein the biological sample is selected from the group consisting of tissue, blood, serum…(‘181, Claim 4.)
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Further, Patent ‘181 exemplifies 8-chloro-N-[4-(trifluoromethoxy)phenyl]quinolin-2-amine, as Compound 1, wherein a use of miR-124, is as a biomarker of an activity for Compound 1 (‘181, Col 6, Lines 39-49, and Claims 6-7 and 10.)
Further, Patent ‘181 teaches an in vitro or ex vivo method for measuring miRNA expressed by one or more cells treated with a candidate compound presumed effective in preventing and/or treating HIV infection, comprising at least the steps of:
Treating at least one isolated cell able of expressing miR-124 with said compound
Measuring a presence or an expression level of at least one miRNA, including miR-124 (‘181, Claim 12 and 14)
Comparing said measured presence to an untreated isolated cell to determine efficacy (‘181, Claim 13.)
While Patent ‘181 fails to teach the biomarker or treatment of Coronaviridae infection specifically, and in preferred embodiments focuses on treatment for HIV, it does teach miR-124 can be used as a biomarker of a viral infection or of an efficacy of a therapeutic treatment of said viral infection (‘181, Col 3, Lines 53-54), with compound 1 (‘181, Col 3, Lines 60-63.)
Additionally, Garcel teaches quinoline derivatives of Formula (I), shown top right, or anyone of its pharmaceutically acceptable salt, or anyone of its metabolites, for use for treating or preventing a viral infection, (‘940, Pg. 1 Abstract), to include viruses, and in particular retroviruses such as HIV, and coronaviruses (‘940, Pg. 6, Para 0059.) Garcel exemplifies compounds of Formula I, such as compound 22 (‘940, Pg. 16, Table A, Compound 22), shown middle right, and its N-glucuronide metabolite (‘940, Pg. 8, Para 0074), shown bottom right.
As, Garcel teaches compound 1 treats both of the viral infections HIV and coronaviruses, Patent ‘181’s claims for treating HIV, and the instant application claims for treating Coronaviridae, using the same compound are not patentably distinct.
Claims 23, 38-42 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 47, 51, 65-66, and 70-73 of copending Application No. 17/416,988 (reference application). MAINTAINED
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed compound and methods of use are suggested and/or exemplified within the instant application and are therefore anticipated or an obvious variation of the reference claims.
While Application ‘988 does not focus on Coronaviridae infection, the instant claims include conditions related thereto, which include reducing inflammation (as in instant Claim 42 and reference Claim 51.) In addition, Application ‘988 focuses on detecting of miR-124, which has been shown to be indicative of Group IV viruses.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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