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 is a national stage entry of PCT/US21/44969 filed on 08/06/2021 which claims priority to U.S. Provisional Application No. 63/062,093 filed on 08/06/2020.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-9) drawn to a method of treating coronavirus infection comprising administering a compound of formula I or II in the reply filed on January 30, 2026 is acknowledged. The traversal is on the ground(s) that Groups I-IV share a common activity and common structural element because the claims in Group II are directed towards a method for treating coronavirus infection by administering an inhibitor of SAH hydrolase, compounds of Formula I and Formula II as in Group III are inhibitors of SAH hydrolase, also used in the method for treating coronavirus infection as in Group I, and is used in an inhaler as in Group IV. Thus, Applicant argues that Groups I-IV have common physical properties in inhibiting SAH hydrolase and treating coronavirus infection. Applicant argues that Groups I-IV share several special technical features that are not present in the prior art and therefore possess unity of invention since Yin et al. (Tetrahedron 61 (2005) pages 1839-1843), does not disclose using an inhibitor of SAH hydrolase to treat coronavirus infection.
This is not found persuasive because the common feature among all groups is a compound of formula I as detailed in the restriction requirement (see pages 5-6). Groups III and IV do not require the treatment of coronavirus and as such all groups do not possess a common feature of treating coronavirus infection. Therefore, as detailed on page 6 of the restriction requirement, no special technical feature exists among the different groups of inventions since the technical feature which is a compound of formula I fails to make a contribution over the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election without traverse of a compound of formula I as a species of a compound of formula I or II; and SARS-CoV-2 as a species of coronavirus in the reply filed on January 30, 2026 is also acknowledged.
Claims 3, 10-16, 18 and 24-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species or group, there being no allowable generic or linking claim.
Claims 1, 2 and 4-9 are being examined as they read on the elected species.
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 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.
Claims 1, 2 and 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Prendergast et al. U.S. Publication No. 2021/0299143 A1 (earliest priority date March 27, 2020).
Claims 1, 2 and 4-9 of the instant application claim a method of treating coronavirus infection, specifically SARS-CoV-2 infection, in a subject, comprising administering to the subject a compound of Formula I such as
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(Aristeromycin) or
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(5'-Noraristeromycin).
Prendergast et al. teaches that coronaviruses are related viruses that cause disease in mammals including humans [0005] . Coronaviruses include SARS-CoV, or SARS-CoV-1, which produces Severe Acute Respiratory Syndrome (SARS), MERS-CoV, which produces Middle East Respiratory Syndrome (MERS), and SARS-CoV-2, which produces the Coronavirus Disease 2019 (COVID-19) [0005] .
Prendergast et al. teaches that calcium channel blockers may also work synergistically with the NSF receptor antagonists to undermine the pathogenicity of coronaviruses and stabilize vascular endothelial cells, which may, in some cases, result in a broad-spectrum inhibition of viral stimulated inflammatory symptoms [0034]. Furthermore, it has been found that certain therapeutic agents administered with the NSF receptor antagonist and/or the calcium channel blockers may also provide additional therapeutic effects in the treatment of coronavirus infections [0034].
Prendergast et al. teaches administering to a subject an amount of at least one NSF receptor antagonist, and optionally a calcium channel blocker and/or a therapeutic agent, for the treatment or prevention of a coronavirus infection [0075]. Such compositions may be therapeutically effective to inhibit coronavirus replication, may lower the circulating viral load, and may treat or prevent vascular endothelial instability, muscle pain, and rheumatic pain which the subject may suffer from the coronavirus infection [0075].
Prendergast et al. teaches that the methods and compositions may be used to treat any coronavirus in the family of Coronaviridae, for example SARS-CoV, or SARS-CoV-1, which produce Severe Acute Respiratory Syndrome (SARS), MERS-CoV, which produces Middle East Respiratory Syndrome (MERS), and SARS-CoV-2, which produces the Coronavirus Disease 2019 (COVID-19) [0076]. In particular embodiments of the invention, the methods and compositions are used to treat or prevent the viral infection by SARS-CoV-2 and/or treat the symptoms produced by COVID-19 [0076]. Prendergast et al. teaches treating COVID-19 refers to both treatment of SARS-CoV-2 virus, or any mutated or related viral strain thereof, and treating the symptoms of COVID-19 [0076].
Prendergast et al. teaches that the subject can be a subject that has been tested and confirmed to have been infected with a coronavirus; a subject that is experiencing symptoms consistent with coronavirus; a subject that is suspected of having infection by a coronavirus; and/or is a subject that is anticipated to become exposed to a coronavirus, such that the methods and compositions of the invention are used for therapeutic and/or prophylactic treatment [0078].
Prendergast et al. specifically teaches that the additional therapeutic agent is an antiviral agent [0081]. Prendergast et al. teaches that examples of antiviral agents that may be administered concurrently or sequentially with the compositions of the invention include, without limitation, several compounds of formula I and II as claimed in the current claims including: Carbocyclic 3-deazaadenosine (C-c3Ado), R- and S-isomers of 6′-C-neplanocin A analogues, carbocyclic analogues of adenosine, aristeromycin (carbocyclic adenosine), carbocyclic 3-deazaadenosine, neplanocin A (NepA), 3-deazaneplanocin A, 5′-nor derivatives of aristeromycin, carbocyclic 3-deazaadenosine, 2-halo (e.g., 2-fluoro) and 6′-R-alkyl (e.g., 6′-R-methyl) derivatives neplanocin A, 9-(hydroxyalkenyl)purines (adenines and 3-deazaadenines), which analogues of neplanocin A, 3-deazaneplanocin A, bromine epiandrosterone, the 5′-nor derivatives of carbocyclic adenosine (C-Ado, aristeromycin), the 2-halo (i.e., 2-fluoro) and 6′-R-alkyl (i.e., 6′-R-methyl) derivatives of neplanocin A, 6′-C-methylneplanocin A (isomers I and II), 5′-noraristeromycin, (S)-9-(2,3-dihydroxypropyl)adenine, 5′-nor derivatives of carbocyclic adenosine (C-Ado, aristeromycin), 2-halo (i.e., 2-fluoro) and 6′-R-alkyl (e.g., 6′-R-methyl) derivatives of neplanocin A, 9-(hydroxyalkyl)-3-deazaadenines, which are analogues of the carbocyclic derivative of 3-deazaadenosine (3-deaza-C-Ado), and homodimer enzyme inhibitory antibodies to SAH inhibitors [0081].
Prendergast teaches that the compositions can be administered to a patient in any suitable route such as by oral, rectal, subcutaneous, and intravenous administration [0093]. Prendergast further teaches that any suitable pharmaceutical formulation or dosage form may be used to administer the active compounds and in some embodiments, one or more of the active compounds are in a liquid form suitable for intravenous administration [0055]. In some embodiments, one or more of the active compounds are provided in a form suitable for oral administration [0055]. In yet further embodiments, one or more active compounds are present in a liquid preparation suitable for subcutaneous injection [0055]. Prendergast further teaches that other forms include powders and micronized particles for inhalation and controlled release forms thereof [0055]. Prendergast teaches that in some embodiments, all of the active compounds are present in one dosage form, to be used in a combination formulation [0055].
Claims 1, 15 and 16 of Prendergast specifically claim a method of treating or preventing a coronavirus infection in a subject in need thereof, comprising administering to the subject a nuclear steroid family (NSF) receptor antagonist and a calcium channel blocker, in an amount effective to treat or prevent the coronavirus infection, and further comprising administering to the subject at least one additional therapeutic agent, wherein the at least one additional therapeutic agent is an antiviral agent which may be selected as
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aristeromycin (carbocyclic adenosine), carbocyclic 3-deazaadenosine, neplanocin A (NepA) (compound of formula II), 3-deazaneplanocin A, 5′-nor derivatives of aristeromycin, carbocyclic 3-deazaadenosine, 2-halo and 6-R-alkyl derivatives, neplanocin A, 9-(hydroxyalkenyl)purines (adenines and 3-deazaadenines), which analogues of neplanocin A, 3-deazaneplanocin A, bromine epiandrosterone, the 5′-nor derivatives of carbocyclic adenosine (C-Ado, aristeromycin), the 2-halo (i.e., 2-fluoro) and 6′-R-alkyl (i.e., 6′-R-methyl) derivatives of neplanocin A, 6′-C-methylneplanocin A (isomers I and II), 5′-noraristeromycin
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, and other SAH inhibitors of Formula I and II as claimed.
Thus Prendergast teaches and claims that compounds of formula I including 5'-Noraristeromycin and Aristeromycin can be used in a method for treating coronavirus infection, and specifically COVID-19 (SARS-CoV-2) infection.
Prendergast does not specifically exemplify treating SARS-CoV-2 infection comprising the administration of 5'-Noraristeromycin or Aristeromycin.
However, Prendergast teaches and claims that compounds of formula I including 5'-Noraristeromycin and Aristeromycin can be used in a method for treating SARS-CoV-2 infection and thus a person of ordinary skill in the art would have been motivated to select said compounds with a reasonable expectation of success. Thus, although Prendergast includes 5'-Noraristeromycin and Aristeromycin on a list that includes other antiviral agents, a prima facie case of obviousness can still be established since picking one of a finite number of known solutions to a known problem is prima facie obvious. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007).
Thus the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Prendergast et al. U.S. Publication No. 2021/0299143 A1 as applied to claims 1, 2 and 4-8 above and further in view of Tahamtan et al. (Expert Review of Molecular Diagnostics 2020 Apr 22:1-2.doi: 10.1080/14737159.2020.1757437).
Claim 9 of the instant application claims the subject has SARS-CoV-2 infection, which has been confirmed by reverse-transcription polymerase chain reaction (RT-PCR) from respiratory tract or blood specimens.
Prendergast et al. is as set forth above.
Prendergast et al. does not teach reverse-transcription polymerase chain reaction.
However, claim 9 of the instant application is rendered obvious since Prendergast et al. teaches that the subject can be a subject that has been tested and confirmed to have been infected with a coronavirus [0078] and Tahamtan et al. teaches that the RT-PCR assay can be considered as a main method to be applied to detect the causative agent of COVID-19, SARS-CoV-2, wherein sputum is the most accurate sample for laboratory diagnosis of COVID-19, followed by nasal swabs, and blood and stool may also be sampled (page 1).
Thus claim 9 of the instant application is rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 1, 2 and 4-9 are rejected. Claims 3, 10-16, 18 and 24-26 are withdrawn. Claims 17, and 19-23 are canceled. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM