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.
Response to Amendment
Applicant’s amendment filed on July 9, 2026 amending claims 1 and 18, cancelling claim 26, and adding new claim 27 has been entered. Claims 3, 10-16, 18 and 24-25 are withdrawn. Claims 17, and 19-23 are canceled. Claims 1, 2, 4-9 and 27 are being examined as they read on the elected species.
Response to Arguments
Applicant's arguments filed July 9, 2026 have been fully considered but they are not persuasive.
Applicant argues that Prendergast does not teach any compound as claimed of formula I for the treatment of coronavirus infection. Applicant argues that the invention of Prendergast is concerned with the administration of a nuclear steroid family (NSF) receptor antagonist for the treatment of a coronavirus infection. Applicant argues that the only place in Prendergast where aristeromycin and 5'-noraristeromycin appear is in the description of an "additional therapeutic agent" that may be "delivered to a subject concurrently or sequentially" with Prendergast's active compounds: the NSF receptor antagonist and calcium channel blocker and Prendergast expressly frames this additional agent as optional: the invention "contemplates administering to a subject an amount of at least one NSF receptor antagonist, and optionally a calcium channel blocker and/or a therapeutic agent. Applicant further argues that Prendergast presents many dozens of antiviral compounds as merely optional adjuncts with no indication if any would be effective against SARS-CoV-2. Applicant further argues that the claimed method requires abandoning the very feature Prendergast identified as essential to its invention, that the therapeutic benefit against coronavirus flows from antagonizing the NSF receptor system to prevent aldosterone-mediated endothelial instability and inflammatory cascade. Prendergast explains that the "advantage of administering a pharmaceutical formulation containing at least one antagonist of the nuclear steroid receptor family" is that the NSF antagonist inhibits coronavirus replication and provides immune-regulatory benefits. Applicant argues that Prendergast does not teach administering an antiviral agent in the absence of the NSF antagonist.
These arguments are found not persuasive since the claims of the instant application claim a method of treating coronavirus infection, in a subject, comprising administering to the subject a compound of Formula I. Thus the claims of the instant application utilize comprising language and thus does not exclude the administration of additional therapeutic compounds even as the main therapeutic component. Thus the claims of the instant application merely require administration of formula I as part of a treatment for coronavirus infection. The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“like the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended.”). Invitrogen Corp. v. Biocrest Manufacturing, L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) (“The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the court held that a claim to “a safety razor blade unit comprising a guard, a cap, and a group of first, second, and third blades” encompasses razors with more than three blades because the transitional phrase “comprising” in the preamble and the phrase “group of” are presumptively open-ended. “The word ‘comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended.” Id. In contrast, the court noted the phrase “group consisting of” is a closed term, which is often used in claim drafting to signal a “Markush group” that is by its nature closed. Id. The court also emphasized that reference to “first,” “second,” and “third” blades in the claim was not used to show a serial or numerical limitation but instead was used to distinguish or identify the various members of the group.
In the instant case, Prendergast teaches an embodiment wherein antiviral agents may be administered concurrently or sequentially with the other compounds including 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] and claim 16).
It has been well established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches, when viewed in light of the admitted knowledge in the art, to a person of ordinary skill in the art. In re Boe, 355 F.2d 961,148 USPQ 507, 510 (CCPA 1966); In re Lambedi, 545 F.2d 747, 750, 192 USPQ 279,280 (CCPA 1976): In re FracalossL 681 F.2d 792,794, 215 USPQ 569, 570 (CCPA 1982)4 In re Kaslow, 707 F.2d 1366, 13:4,217 USPQ 1089, 1095 (Fed. Cir. 1983). Furthermore, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or non-preferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (The invention was directed to an epoxy impregnated fiber-reinforced printed circuit material. The applied prior art reference taught a printed circuit material similar to that of the claims but impregnated with polyester-imide resin instead of epoxy. The reference, however, disclosed that epoxy was known for this use, but that epoxy impregnated circuit boards have “relatively acceptable dimensional stability” and “some degree of flexibility,” but are inferior to circuit boards impregnated with polyester-imide resins. The court upheld the rejection concluding that applicant’s argument that the reference teaches away from using epoxy was insufficient to overcome the rejection since “Gurley asserted no discovery beyond what was known in the art.” 27 F.3d at 554, 31 USPQ2d at 1132.). Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
In the instant case, Prendergast specifically teaches that the NSF receptor antagonist may be combined with another antiviral agent such as the compounds of Formula I and II as claimed in the instant application. Since these compounds are specifically taught as antiviral agents, an ordinary skilled artisan would have been motivated to combine these antiviral agents with the NSF receptor antagonist with a reasonable expectation of improving the antiviral properties for the treatment of the coronavirus infection.
Applicant’s argument that the claimed method requires abandoning the very feature Prendergast identified as essential to its invention, i.e. the therapeutic benefit against coronavirus flows from antagonizing the NSF receptor system to prevent aldosterone-mediated endothelial instability and inflammatory cascade, is found not persuasive since the rejection of record does not argue that Prendergast would administer the antiviral agents without the NSF receptor antagonist. This is because the instant claims utilize comprising language and as such do not exclude the administration of additional compounds such as the compounds taught in Prendergast.
Applicant’s argument that Prendergast teaches an unreasonably large number of antiviral compounds is found not persuasive in view of claim 16 of Prendergast which specifically claims numerous compounds as claimed of formula I and II including Aristeromycin and 5'-Noraristeromycin and other SAH inhibitors. Thus even though there are numerous compounds claimed in claim 16 of Prendergast, the list is nevertheless a finite list. Thus although Prendergast includes the claimed compounds of formula I and II 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).
Applicant’s arguments with respect to the remaining rejection in further view of Tahamtan are found not persuasive for the same reasons as detailed above since Applicant does not provide any additional arguments for this rejection.
Thus, for these reasons, the previous rejections under 35 USC 103 are hereby maintained and reproduced below. New claim 27 is being rejected on the same grounds.
This action is FINAL.
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, 4-8 and 27 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, 4-8 and 27 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).
With respect to new claim 27 which claims the compound of Formula I is administered alone, this limitation is met by the teachings of Prendergast which teaches that the antiviral agents may be administered concurrently or sequentially with the compositions of the invention. Thus sequential administration allows for the administration of the compounds separately and thus the NSF compound may be administered alone followed by the administration of the additional antiviral agent alone.
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, 4-8 and 27 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, 4-9 and 27 are rejected. Claims 3, 10-16, 18 and 24-25 are withdrawn. Claims 17, 19-23 and 26 are canceled. No claims are allowed.
THIS ACTION IS MADE FINAL. 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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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
