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/US2021/059799, filed 11/18/2021; PCT/US2021/059799 Claims Priority from Provisional Application 63116108, filed 11/19/2020.
Status of Action/Claims
Receipt of Remarks/Amendments filed on 3/16/2026 is acknowledged. Claims 1, 4, 10-13, 16-17, 21, 24, 26-28, 31, 38-39, 42-43 and 49 are currently pending and presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
New Claim Objections/Rejections Necessitated by Claim Amendments
Claim Objections
Claim 24 is objected to because of the following informalities:
In the recitation “(2R,3R,4S,5R)-2-(4-aminopyrrolo[2,1-f][ 1,2,4]triazin-7-yl)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-carbonitrile)” of claim 24, the parenthesis after “carbonitrile” should be deleted.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1, 4, 10, 16-17, 21, 26-28, 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bhakay et al (Powder Technology, 2013, 236:221-234) as evidenced by Petersen (Chem. Rev. 2014, 114, 12088-12107).
Bhakay teaches that the known methods of drying of nanoparticulate drug suspensions can lead to the loss of the surface area of the nanoparticles during dissolution, thus decreasing the dissolution rate or the bioavailability (paragraph bridging pages 221-222). Bhakay teaches nanoparticles of griseofulvin, a BCS class II drug (page 222, col. 2). As evidenced by Petersen, griseofulvin also has antiviral effect (e.g., Introduction paragraph of Petersen). Bhakay teaches nanosuspensions of griseofulvin (GF) were prepared by wet media milling and subsequently dried through coating on Pharmatose carrier particles in a fluidized bed processor (abstract). Pharmatose carrier comprises lactose which reads on wherein the excipient is hydrophilic, sugar and lactose. While Bhakay teaches employing various excipients i.e., hydroxypropyl cellulose (HPC), sodium dodecyl sulfate, with mannitol as a dispersant, Bhakay also tested nanosuspensions without any stabilizers as seen in Table 1 and described in Materials and Methods, section 2.1. According to Run 1 in Table 1, the drug nanosuspensions were prepared by mixing water (without any additives) and subsequently coated on Pharmatose® carrier particles. Section 2.3 describes the coating griseofulvin nanosuspension on carrier particles and further drying resulting in lactose particle core coated with griseofulvin nanoparticles (table 2). The particle sizes of Pharmatose ranges in micron sizes and specifically 58-206 micron (section 2.3.), which reads on claim 21. Table 2 discloses particle size of griseofulvin suspension with no stabilizers ranges from 289 nm to 4708 nm, which reads on claim 26. The composition of suspensions sprayed on Pharmatose have a particle size of about 10-100 micron (see e.g. Fig. 5), which reads on claim 28. Section 3.1.2 describes that the yields of the coating process for Run 1 (as well as 2-8) was acceptably high.
Thus, Bhakay teaches coated particles (Run 1) which read on the instantly claimed coated particles and further meets the carrier/excipient recited in instant claims. For claim 31, instant claim does not recite any additional components other than the coated particle of claim 1. Accordingly, the coated particles of Bhakay (Run 1 sample) reads on the instant pharmaceutical composition. For claim 27, Bhakay teaches that the drug content of Run 1 is 6.3% (section 3.1.2).
Even though instant claims recite “vapor-phase-deposited” nanoparticles, the said limitation reflects a process step. Further, claim 4 recites the steps of preparing the composition. However, the claims are directed to a product. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, Bhakay anticipates instant claims.
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.
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 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Bhakay et al (Powder Technology, 2013, 236:221-234) as evidenced by Petersen (Chem. Rev. 2014, 114, 12088-12107) as applied to claims 1, 4, 10, 16-17, 21, 26-28, 31 above and further in view of Jain et al. (US 6316029).
The teachings of Bhakay have been set forth above.
Bhakay does not teach the claimed sugar alcohols (e.g. mannitol) as the carrier particles. However, Jain cures this deficiency.
Jain teaches rapidly disintegrating solid oral dosage form of poorly soluble active ingredient and at least one pharmaceutically acceptable excipient. Jain teaches pharmaceutically acceptable excipient include mannitol and lactose and a nanoparticulate dispersion of the poorly soluble active ingredient (ketoprofen or naproxen) was sprayed on fluidized spray dried mannitol or lactose. Thus, Jain teaches a core made of mannitol or lactose coated with the active such as ketoprofen or naproxen (see e.g. abstract; claims; examples; entire document).
It would have been prima facie obvious to one skilled in the art before the effective filing date of the claimed invention to have combined the teachings of Bhakay and Jain and include specifically lactose as the carrier in the formulation of Bhakay. One of an ordinary skill in the art would have been motivated to prepare the solid oral dosage form of Bhakay with any other carrier particle in the core, including mannitol, along with or in place of lactose (of Bhakay) because Jain is also concerned with rapidly disintegrating solid oral dosage form of nanoparticulate drugs, wherein the drug is a poorly soluble active BCS class II drug and teaches both lactose (example 1) and mannitol (example 3) as suitable core particles for drug nanoparticle coating. One of an ordinary skill in the art would have expected to effectively prepare a nanosuspension of any of the above BCS class II drugs and a sugar alcohol (mannitol) or lactose core and still expect to achieve a desired dissolution and bioavailability. It would have been obvious to one of ordinary skill in the art to substitute the known types of sugar carrier (such as lactose or mannitol) on which the drug is deposited as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. see MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 24, 38-39, 42-43 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Bhakay et al (Powder Technology, 2013, 236:221-234) as evidenced by Petersen (Chem. Rev. 2014, 114, 12088-12107) as applied to claims 1, 4, 10, 16-17, 21, 26-28, 31 above and further in view of EMA (European Medicines Agency; June 25, 2020)(previously cited) as evidenced by Chen (International Journal of Nanomedicine 2021:16)(previously cited).
The teachings of Bhakay have been set forth above.
Bhakay teaches increasing dissolution rate of poorly water soluble drug (BCS Class II drugs) and specifically griseofulvin (BCS Class II drug) was chosen as model drug which has low solubility in water (see: Introduction; Materials and methods). Bhakay does not teach wherein the drug coated onto the carrier is specifically an antiviral recited in claim 24. Bhakay also does not teach the methods of claims 38-39, 42-43, and 49. However, the EMA reference cures this deficiency.
EMA teaches remdesivir which reads on the antiviral which is 2-ethylbutyl ((S)-(((2R,3S,4R,5R)-5-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-5-cyano-3,4-dihydroxytetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)-L-alaninate, as recited in claim 24. EMA teaches Remdesivir having low aqueous solubility (see e.g., section 2.2.2; 2.2.3.1; and 2.3.4 – Mechanistic studies). As evidenced by Chen, remdesivir is a BCS class II drug (see e.g., Table I). EMA teaches that remdesivir is a novel antiviral drug that has been evaluated for the treatment of COVID-19 viral infection (e.g., page 8/199). Remdesivir inhibits viral RNA polymerases and viral replication and has antiviral activity against members of the filoviruses (e.g., EBOV, MARV), coronaviruses (e.g., SARS-CoV, MERS-CoV, SARS-CoV-2), and paramyxoviruses (e.g., respiratory syncytial virus [RSV], Nipah virus [NiV], and Hendra virus) (page 34, 75, 62). Subjects were treated with Remdesivir and Remdesivir treatment resulted in significantly lower levels of SARS-CoV-2 replication in the lungs (page 67). In the subgroup of patients receiving remdesivir or placebo within 10 days of symptom onset, those receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo (page 115). Thus, EMA teaches an effective amount of remdesivir which treats the viral infection and/or inhibits replication of the virus.
It would have been prima facie obvious to one skilled in the art before the effective filing date of the claimed invention to have combined the teachings of Bhakay and EMA and substitute the griseofulvin taught by Bhakay with remdesivir. Bhakay teaches increasing dissolution rate of poorly water soluble drug (BCS Class II drugs) and specifically griseofulvin (BCS Class II drug) was chosen as model drug which has low solubility in water. EMA teaches Remdesivir (BCS class II antiviral drug) also having low aqueous solubility. Thus, one skilled in the art would have been motivated to substitute the griseofulvin taught by Bhakay with remdesivir as both are taught to have low solubility in water and being BCS class II antiviral drugs.
It would also have been prima facie obvious to one skilled in the art before the effective filing date of the claimed invention to have combined the teachings of Bhakay and EMA and use remdesivir taught by EMA to treat, reduce severity of symptoms of viral infection and severe acute respiratory syndrome or inhibit virus replication in a subject by administering to the subject a therapeutically effective amount of the formulation comprising remdesivir. As discussed supra, EMA teaches that remdesivir is a novel antiviral drug that has been evaluated for the treatment of COVID-19 viral infection (e.g., page 8/199). Remdesivir inhibits viral RNA polymerases and viral replication and has antiviral activity against members of the filoviruses (e.g., EBOV, MARV), coronaviruses (e.g., SARS-CoV, MERS-CoV, SARS-CoV-2), and paramyxoviruses (e.g., respiratory syncytial virus [RSV], Nipah virus [NiV], and Hendra virus) (page 34, 75, 62). Subjects were treated with Remdesivir and Remdesivir treatment resulted in significantly lower levels of SARS-CoV-2 replication in the lungs (page 67). In the subgroup of patients receiving remdesivir or placebo within 10 days of symptom onset, those receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo (page 115). Thus, EMA teaches an effective amount of remdesivir which treats the viral infection and/or inhibits replication of the virus. Therefore, in view of the teachings of Bhakay and EMA one skilled in the art would have found it obvious to a to treat, reduce severity of symptoms of viral infection and severe acute respiratory syndrome or inhibit virus replication in a subject by administering to the subject a therapeutically effective amount of the formulation comprising remdesivir.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant’s arguments regarding the previous 102 and 103 rejections are rendered moot in view of the new 102 and 103 rejections above which are necessitated by claim amendments and do not utilize the previously cited primary references.
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 1, 4, 10-13, 16-17, 21, 24, 26-28, 31, 38-39, 42-43 and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12370145B2 in view of EMA (European Medicines Agency; June 25, 2020).
‘145 patent recites a coated particle consisting of: (i) a microparticle consisting of a pharmaceutically acceptable excipient and (ii) nanoparticles consisting of a therapeutic agent; wherein the surface of the microparticle is coated with the nanoparticles; wherein the therapeutic agent is a BCS class II or IV compound; and wherein the nanoparticles have an average particle size ranging from about 10 to about 500 nm. The difference between ‘145 and instant claims is that ‘145 does not teach the nanoparticles are of an antiviral drug such as remdesivir and the method of treating/preventing viral infections. However, EMA cure these deficiencies.
The teachings of EMA discussed supra are incorporated herein.
It would have been prima facie obvious to one skilled in the art before the effective filing date of the claimed invention to have combined the teachings of ‘145 and EMA and include remdesivir as the therapeutic agent drug and use remdesivir taught by EMA to treat, reduce severity of symptoms of viral infection and severe acute respiratory syndrome or inhibit virus replication in a subject by administering to the subject a therapeutically effective amount of the formulation comprising remdesivir. As discussed supra, EMA teaches that remdesivir is a novel antiviral drug that has been evaluated for the treatment of COVID-19 viral infection (e.g., page 8/199). Remdesivir inhibits viral RNA polymerases and viral replication and has antiviral activity against members of the filoviruses (e.g., EBOV, MARV), coronaviruses (e.g., SARS-CoV, MERS-CoV, SARS-CoV-2), and paramyxoviruses (e.g., respiratory syncytial virus [RSV], Nipah virus [NiV], and Hendra virus) (page 34, 75, 62). Subjects were treated with Remdesivir and Remdesivir treatment resulted in significantly lower levels of SARS-CoV-2 replication in the lungs (page 67). In the subgroup of patients receiving remdesivir or placebo within 10 days of symptom onset, those receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo (page 115). Thus, EMA teaches an effective amount of remdesivir which treats the viral infection and/or inhibits replication of the virus. Therefore, in view of the teachings of EMA one skilled in the art would have found it obvious to include remdesivir in the formulation of ‘145 to treat, reduce severity of symptoms of viral infection and severe acute respiratory syndrome or inhibit virus replication in a subject by administering to the subject a therapeutically effective amount of the formulation comprising remdesivir.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 1, 4, 10-13, 16-17, 21, 24, 26-28, 31, 38-39, 42-43 and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 40, 42, 44, 46, 48-55, 57-58, 60, 62-63, 66-68 of copending application no. 18/322,693 (US20230310321A1) in view of EMA (European Medicines Agency; June 25, 2020).
‘693 application recites a method of preparing coated particles, each coated particle consisting of: (i) a microparticle consisting of a pharmaceutically acceptable excipient and (ii) nanoparticles consisting of a therapeutic agent; wherein the surface of the microparticle is coated with the nanoparticles; wherein the therapeutic agent is a BCS class II or IV compound; and wherein the nanoparticles have an average particle size ranging from about 10 to about 500 nm. The difference between ‘693 and instant claims is that ‘693 does not teach the nanoparticles are of an antiviral drug such as remdesivir and the method of treating/preventing viral infections. However, EMA cure these deficiencies.
The teachings of EMA discussed supra are incorporated herein.
It would have been prima facie obvious to one skilled in the art before the effective filing date of the claimed invention to have combined the teachings of ‘693 and EMA and include remdesivir as the therapeutic agent drug and use remdesivir taught by EMA to treat, reduce severity of symptoms of viral infection and severe acute respiratory syndrome or inhibit virus replication in a subject by administering to the subject a therapeutically effective amount of the formulation comprising remdesivir. As discussed supra, EMA teaches that remdesivir is a novel antiviral drug that has been evaluated for the treatment of COVID-19 viral infection (e.g., page 8/199). Remdesivir inhibits viral RNA polymerases and viral replication and has antiviral activity against members of the filoviruses (e.g., EBOV, MARV), coronaviruses (e.g., SARS-CoV, MERS-CoV, SARS-CoV-2), and paramyxoviruses (e.g., respiratory syncytial virus [RSV], Nipah virus [NiV], and Hendra virus) (page 34, 75, 62). Subjects were treated with Remdesivir and Remdesivir treatment resulted in significantly lower levels of SARS-CoV-2 replication in the lungs (page 67). In the subgroup of patients receiving remdesivir or placebo within 10 days of symptom onset, those receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo (page 115). Thus, EMA teaches an effective amount of remdesivir which treats the viral infection and/or inhibits replication of the virus. Therefore, in view of the teachings of EMA one skilled in the art would have found it obvious to include remdesivir in the formulation of ‘693 to treat, reduce severity of symptoms of viral infection and severe acute respiratory syndrome or inhibit virus replication in a subject by administering to the subject a therapeutically effective amount of the formulation comprising remdesivir.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant argued the rejections be held in abeyance. Since applicant have not provided any substantial argument regarding the double patenting rejection or filed a terminal disclaimer, the rejections are therefore maintained.
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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/A.S/ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616
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