DETAILED ACTION
Requirement for Restriction/Election was mailed 28 August 2025.
Applicant’s Response to Restriction Requirement was received 26 November 2025 (“Response”).
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 .
Status of the Claims
The listing of claims filed 03 May 2023 has been examined. Claims 1-20 are pending. Claims 3-9 and 11-14 are amended. Claims 16-20 are new.
Information Disclosure Statement
The IDSs submitted on 03 May 2023, 08 November 2024, 12 June 2025, 01 July 2025, and 27 January 2026 are acknowledged and have been considered. Any lined-through references have not been considered and must be submitted or resubmitted in proper format for consideration. For example, a copy of NPL document (Chau Le-Ngoc Vo, et al., “Current trends and future perspectives of solid dispersions containing poorly water-soluble drugs,” European Journal of Pharmaceutics and Biopharmaceutics, Vol. 85, p. 799-813 (2013)) is missing, a foreign patent document (CN 111511365) is entirely in Chinese, lacking any English translation or concise explanation of its relevance (see CFR 1.56(c)), and the document titled “2043343 69 5, STNext REGISTRY, 05 December 2016” is unreadable.
Priority
The instant application was received 03 May 2023; it is a national stage application of PCT/CN2021/128521, filed 03 November 2021. The instant application claims foreign priority to PCT/CN2021/128521, filed 04 November 2020. Acknowledgment is made of applicant’s claim for foreign priority and certified copies of the priority documents have been received.
Election/Restrictions
Applicant’s election in the Response of Group I (Claims 1-12 and 16-19) without traverse is acknowledged. The claims in Group II (Claim 13) and Group III (Claims 14-15 and 20) are withdrawn.
Specification
The abstract of the disclosure is objected to because it contains legal phraseology, specifically the terms “comprising” and “said” (MPEP 608.01(b)(I)(C)). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3 recites “said formulation”. Applicants previously recited the formulation as a “pharmaceutical formulation”. For consistency, Examiner requests all instances of the same formulation be referred to using the same language. Accordingly, Examiner suggests amending “said formulation” in claim 3 to “said pharmaceutical formulation” or similar. Appropriate correction is requested.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, 1st “Written Description” Requirement, Federal Register, Vol. 66, No. 4, p. 1099-1111, Friday, January 4, 2001.
Claim 1 recites an “active pharmaceutical ingredient” which is defined as a dengue viral replication inhibitor. This is a broad genus and, according to its broadest reasonable interpretation, claim 1 includes any active pharmaceutical ingredient which can inhibit Dengue viral replication (MPEP 2164.03). However, only the compounds of Formula (I) have been disclosed in the instant application (Claims 9-10). The disclosed compounds share close structural similarity, so the instant specification lacks sufficient variety in the disclosed compounds to reflect the variance within the genus which is encompassed by the term “active pharmaceutical ingredient.” There may be other, existing compounds that are capable of inhibiting dengue viral replication. However, claim 1 lacks support in the instant specification for any dengue viral replication inhibitors beyond the disclosed indole derivatives in claims 9-10. For example, Kühl (Kühl et al., Journal of Medicinal Chemistry, 2020, 63(15), p. 8179-8197) discloses dengue viral replication inhibitors which attenuate viral replication by inhibiting dengue proteases (Abstract). Kühl’s compounds are encompassed by the claim language “active pharmaceutical ingredient” which is a “dengue viral replication inhibitor,” but Kühl’s compounds, which lack an indole or another aromatic heterocycle, have a distinct structure from the compounds of Formula (I) disclosed in the instant application. Based on the limited number of examples provided for the claimed genus, “dengue viral replication inhibitor” (Formula (I)), a representative number of examples to support the scope of the claimed genus is lacking. A person having ordinary skill in the art (PHOSITA) would conclude that Applicant is not in possession of the claims, as currently recited.
Claim 1 recites “a cellulose derivative.” This is a broad genus which includes many compounds; however, only seven examples have been disclosed in the instant specification (p. 1, line 28 – p. 2, line 1). A “derivative” could include innumerable compounds, including those lacking substantial structural similarity to the starting compound. Furthermore, it is unclear how much structural variance is permitted by the term “cellulose derivative.” The instant specification does not define “derivative,” or disclose how to prepare such a compound and only provides seven examples of cellulose derivatives (methyl cellulose (MC), ethyl cellulose (EC), hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC), carboxymethyl cellulose (CMC), sodium carboxymethylcellulose (NaCMC), and hydroxypropyl methylcellulose (HPMC), or a combination thereof; p. 11, Lines 23-27). Based on the limited number of examples provided for the claimed genus, “cellulose derivative,” a representative number of examples to support the scope of the genus is lacking, and one of ordinary skill in the art would conclude that Applicant is not in possession of the claimed invention, as currently recited.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-5 are rejected under 35 U.S.C. 112(b) on the basis that these claims contain improper Markush groups. Claims 4-5 recite the phrase “selected from the group” which indicates a closed group, while also reciting the open-ended “comprising” transitional phrase. A proper Markush grouping may use the phrase, “selected from the group consisting of A, B, and C” (MPEP 2173.05(h)). The improper Markush language in instant claims 4-5 renders it unclear whether the other alternatives are intended to be considered a closed group as indicated by “selected from the group” or an open group as indicated by “comprising”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4, 6-12, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Mori (JP 2016014019 A) in view of Kesteleyn (WO 2016180696 A1; IDS dated 03 May 2023, Cite No. 12).
Regarding claims 1-2, 4, and 11, Mori teaches a pharmaceutical composition comprising a plus-strand RNA viral replication inhibitor (p. 1, Technical Field) used in treating and/or preventing infectious diseases caused by viruses that express a superfamily 1 (SF1) helicase, which includes the hepatitis E virus (p. 5, Paragraphs 4-5). Other viruses, like dengue and hepatitis C, express SF2 helicases (p. 2, Paragraph 5, Sentence 1). Mori discloses a pharmaceutical composition containing an active ingredient, which is an RNA virus replication inhibitor (p. 6, Paragraph 3; p. 5, Paragraph 3), and a pharmaceutical additive, which may include substances such as sodium carboxymethyl cellulose (NaCMC), hydroxypropyl methylcellulose (HPMC), methyl cellulose (MC), and carboxymethyl cellulose (CMC) (p. 6, Last Paragraph). Furthermore, Mori discloses a solid preparation can be produced for oral administration which includes the active ingredient, a binder like HPMC, and a disintegrant like CMC or calcium carboxymethyl cellulose (CaCMC) (p. 7, First Paragraph). The solid preparation is granulated, and the resultant granules may receive an enteric coating such as hydroxypropylmethylcellulose phthalate, methacrylic acid-methyl methacrylate polymer, or ethylcellulose (EC) (p. 7, First Paragraph).
Mori does not expressly teach the active ingredient is a dengue viral replication inhibitor.
Kesteleyn teaches dengue viral replication inhibitors (Title; p. 3, Lines 9-11).
Kesteleyn does not teach a formulation containing a cellulose derivative or a methacrylic acid copolymer.
It would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention to have modified Mori to incorporate the teachings of Kesteleyn. A skilled artisan would have expected success in substituting Mori’s hepatitis E viral replication inhibitor for Kesteleyn’s dengue viral replication inhibitor because these active pharmaceutical ingredients (APIs) exhibit similar properties in a pharmaceutical composition by inhibiting viral replication and Mori discloses it is favorable to administer an API in a pharmaceutical composition containing one or more pharmaceutical additives (p. 6, Paragraph 3). A PHOSITA would have understood solid formulations which allow pharmaceutical compositions to be administered orally are desirable, but often require an enteric coating to attenuate disintegration in a gastric environment. Furthermore, Kesteleyn discloses an oral dosage composition containing a dengue viral replication inhibitor would be advantageous due to the ease with which capsules and tablets can be administered (p. 7, Lines 31-34). Thus, a PHOSITA would have been motivated to replace the API in the pharmaceutical composition disclosed by Mori with an API disclosed by Kesteleyn to treat a dengue virus infection instead of or in addition to a hepatitis E virus infection.
Regarding claims 6 and 16-17, Mori in view of Kesteleyn teaches all of the elements of the claimed invention as stated above. Furthermore, Mori suggests a skilled artisan can determine the ideal ratio between the API and any additives in the pharmaceutical composition and indicates the composition may be blended in an amount 1-90% by weight based on the API’s weight (p. 6, Last Paragraph).
Kesteleyn suggests the appropriate pharmaceutical composition depends on the route by which it is administered (p. 7, Lines 16-34) and artisans skilled in treating infectious diseases will be able to determine the appropriate API amount, but this will depend on the specific compound of Formula (I) used in the composition and the individual receiving the composition (p. 8, Lines 8-20).
Mori and Kesteleyn do not teach a pharmaceutical formulation containing ≤ 40 wt% API.
It would have been prima facie obvious to a PHOSITA before the effective filing date of the claimed invention to have modified Mori to incorporate the teachings of Kesteleyn to determine the API amount necessary in the pharmaceutical formulation through routine experimentation to achieve the desired inhibitory effect on viral replication (MPEP 2144.05(II)). Furthermore, both Mori and Kesteleyn indicate a skilled artisan could determine the ideal API amount in the formulation.
Regarding claim 7, Mori in view of Kesteleyn teaches all of the elements of the claimed invention as stated above. Furthermore, Mori indicates a lubricant like magnesium stearate or talc may also be included in a solid preparation (p. 7, First Paragraph). In addition, Kesteleyn suggests any “usual pharmaceutical media” may be utilized in when preparing an oral dosage preparation and broadly lists disintegrating agents, binders, diluents, and lubricants as media which may be included (p. 7, Lines 25-31). Kesteleyn indicates choosing appropriate excipients depends on the particular administration method being utilized, as the excipient used in the formulation may have an impact on its solubility and stability (p. 7, Lines 11-15).
It would have been prima facie obvious to a PHOSITA before the effective filing date of the claimed invention to have modified Mori to incorporate the teachings of Kesteleyn and incorporate pharmaceutically acceptable excipients in the pharmaceutical formulation since excipients had been known to help modulate pharmaceutical properties.
Regarding claim 8, Mori in view of Kesteleyn teaches all of the elements of the claimed invention as stated above. Furthermore, Mori teaches an API and pharmaceutically acceptable excipients can be mixed to create a powder, to which a binder like HPC or a disintegrant like CMC may be added in combination with a granulate. Then, a lubricant like magnesium stearate can be added prior to forming the granules into tablets. Mori suggests the resultant tablets should receive an enteric or EC coating and indicates the powder or granules may also be packaged into capsules (p. 7, First Paragraph).
Mori does not use the terms “intragranular phase” and “extragranular phase.”
The instant specification defines the term “intragranular phase” as, “…those components of a formulation that are with granules and/or within granules,” (p. 31, Lines 29-30) and the term “extragranular phase” as, “…those components of a formulation that are outside of the granules” (p. 31, Lines 31-32). The intragranular phase may contain a lubricant, such as magnesium stearate (p. 37, Lines 22-24).
Because Mori indicates granules containing an API and magnesium stearate should receive a coating, the granules and coating are equivalent to the “intragranular phase” and the “extragranular phase,” respectively. Thus, it would have been prima facie obvious to a PHOSITA before the effective filing date of the claimed invention to have modified Mori to incorporate the teachings of Kesteleyn and prepare a pharmaceutical formulation comprising granules containing inner and outer layers (i.e. an intragranular and extragranular phase).
Regarding claims 9-10, Mori in view of Kesteleyn teaches all of the elements of the instant claims as stated above. Furthermore, Kesteleyn teaches the compounds of Formula (I) (p. 4, Lines 1-15; Claim 6) and the specific compound claimed in instant claim 10 (p. 5).
Thus, it would have been prima facie obvious to a PHOSITA before the effective filing date of the claimed invention to have modified Mori to incorporate the teachings of Kesteleyn and prepare a pharmaceutical formulation comprising the compounds of Formula (I) disclosed by Kesteleyn in combination with a methacrylic acid copolymer or a cellulose derivative as disclosed by Mori.
Regarding claims 12 and 18-19, Mori in view of Kesteleyn teaches all of the elements of the claimed invention as stated above. Furthermore, Mori advises adjusting the dosage based on the disease and its progression, suggesting 0.01-1,000 mg API be administered once or in multiple instances per day or every few days or, alternatively, 0.001-100 mg API be administered continuously or intermittently (p. 7, Paragraph 5).
Kesteleyn states a skilled artisan could determine the appropriate dose and an effective daily amount would be 0.01-50 mg/kg body weight, or more preferably 0.1-10 mg/kg body weight (p. 8, Lines 8-15). Assuming the average human body weight is approximately 70 kg, the dose preferred by Kesteleyn would be 7-700 mg. Additionally, Kesteleyn discloses 2-4 smaller sub-doses may be administered periodically throughout a 24-hour period with each sub-dose containing 1-1000 mg API or 5-200 mg API (p. 8, Lines 8-15).
It would have been prima facie obvious to a PHOSITA before the effective filing date of the claimed invention to have modified Mori to incorporate the teachings of Kesteleyn and administer the compounds of Formula (I) in the amounts disclosed by Kesteleyn in combination with the pharmaceutical excipients described by Mori. Furthermore, as stated by Kesteleyn (p. 8, Lines 8-15), a PHOSITA would have known to optimize the API amount via routine experimentation to achieve the desired inhibitory effect on viral replication (MPEP 2144.05(II)).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Mori (JP 2016014019 A) in view of Kesteleyn (WO 2016180696 A1; IDS dated 03 May 2023, Cite No. 12) as applied to claims 1-2, 4, 6-12, and 16-19 above, and further in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11) as evidenced by Bardiot (Bardiot et al., Journal of Medicinal Chemistry, 2018, 61(18), p. 8390-8401).
Regarding claim 3, Mori in view of Kesteleyn teaches all of the elements of the claimed invention as stated above.
However, the combination of Mori and Kesteleyn does not teach a pharmaceutical formulation in which the ratio of the API to either the methacrylic acid copolymer or cellulose derivative is 4:1 w/w to 1:5 w/w.
Huang teaches strategies by which API solubility may be improved to increase its bioavailability (p. 1, Paragraph 2). Huang discloses enteric polymers, which includes cellulose derivatives including cellulose acetate phthalate (CAP), hydroxypropyl methylcellulose phthalate (HPMCP), hydroxypropyl methylcellulose acetate succinate (HPMCAS), and CMC, have pH-dependent solubility which helps prevent solubilization in a gastric environment and allows solubilization when the pH increases to about pH 5 (p. 12, Lines 22-30). Huang also discloses gastric-soluble polymers, including methacrylic acid copolymers, which solubilize in a gastric environment (p. 12, Lines 31-35 – p. 13, Lines1-9). Further, Huang provides exemplary pharmaceutical preparations comprising an API and an excipient. In one example, Huang discloses a preparation containing diclofenac, HPMC, and HPMCAS in an approximately 2:4:4 weight ratio (p. 37, Lines 12-17). Diclofenac is the API and HPMC and HPMCAS are cellulose derivatives, so the API to cellulose derivative ratio is 1:4.
Huang does not expressly teach the active ingredient is a dengue viral replication inhibitor.
Bardiot investigates indole derivatives and dengue virus inhibitors (Figs. 1-2; Abstract) and introduces various structural groups to increase solubility whilst minimizing off-target activity (p. 8396, Col. 1). Bardiot postulates the oral bioavailability of indole derivatives could be improved by increasing their solubility (p. 8396, Col. 2, Paragraph 3) and does so by introducing new substituents on the indole. Thus, Bardiot indicates indole derivatives have utility as dengue virus inhibitors, but acknowledges solubility as a challenge with these compounds and suggests the compounds’ pharmaceutical properties should be further optimized (p. 8398, Conclusion).
Bardiot does not teach a formulation containing a cellulose derivative or a methacrylic acid copolymer.
It would have been prima facie obvious to a PHOSITA before the effective filing date of the claimed invention to have modified Mori to incorporate the teachings of Kesteleyn and Huang and prepare a pharmaceutical preparation containing the compounds of Formula (I) disclosed by Kesteleyn together with the excipients described by Mori and Huang in the ratios disclosed by Huang. Like the compounds described by Bardiot, the compounds of Formula (I) described by Kesteleyn and the instant application are indole derivatives. Since Bardiot demonstrates indole derivatives can have limited solubility leading to poor bioavailability, a PHOSITA would have been motivated to seek means by which indole derivatives’ solubility could be improved. Huang discloses numerous approaches to improve API solubility, so a PHOSITA would have had a reasonable expectation of success in combining the teachings of Mori and Kesteleyn with Huang to conclude administering indole derivatives with pharmaceutically acceptable excipients would likely lead to improved pharmaceutical characteristics.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Mori (JP 2016014019 A) in view of Kesteleyn (WO 2016180696 A1; IDS dated 03 May 2023, Cite No. 12) as applied to claims 1-2, 4, 6-12, and 16-19 above, and further in view of Cai (WO 2016161990 A2).
Regarding claim 5, Mori in view of Kesteleyn teaches all of the instantly claimed elements of the claimed invention as stated above.
However, the combination of Mori and Kesteleyn does not expressly teach a pharmaceutical formulation wherein the cellulose derivative has a viscosity between 3-5,000 mPa·s in 2 wt% solution in H2O at 25°C and is HPMC E5, HPMC E6, HPMC E15, HPMC E50, HPMC K4M, or HPMC-AS.
Cai teaches a coating method wherein the coating is HPMC having a viscosity between 30-60 mPa·s like HPMC E50 or 2.2-10 mPa·s like HPMC E5 or HPMC E6 (p. 3, Paragraph 3, Middle). Furthermore, Cai discloses HMPC is dissolved in H2O (p. 5, Paragraph 2, Sentence 1), the mass percentage HPMC is 5-10% (p. 5, Paragraph 3, Last Sentence), and the coating process occurs at between 35-60°C (p. 5, Paragraph 3).
Cai does not teach a 2 wt% solution at 25°C or an API which is a viral replication inhibitor.
It would have been prima facie obvious to a PHOSITA before the effective filing date of the claimed invention to have modified Mori to incorporate the teachings of Kesteleyn and Cai and prepare a pharmaceutical formulation comprising the API compounds of Formula (I) described by Kesteleyn in combination with the cellulose derivatives as disclosed by Mori in the amounts and under the conditions described by Cai. A skilled artisan would have expected the cellulose derivative to become more viscous at lower temperatures and less viscous at higher temperatures. Thus, a PHOSITA would have known to optimize the HPMC concentration to via routine experimentation to achieve the desired viscosity (MPEP 2144.05(II)). In addition, Cai indicates too much HPMC results in a coating which is to too viscous to be sprayed whereas too little HPMC causes the coating efficiency to be poor (p. 5, Paragraph 2).
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 and 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 10,696,632 B2 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘632 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘632’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).
A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claims 1 and 9-10 in the instant application would have been obvious over claim 2 of ‘632 in view of Huang, claims 1 and 9-10 of the instant application are not patentably distinct from claim 2 of ‘632.
Claims 1 and 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 10,919,854 B2 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘854 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘854’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).
A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claims 1 and 9-10 in the instant application would have been obvious over claims 1-27 of ‘854 in view of Huang, claims 1 and 9-10 of the instant application is not patentably distinct from claims 1-27 of ‘854.
Claims 1 and 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 12,172,959 B2 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘959 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘959’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).
A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claims 1 and 9-10 in the instant application would have been obvious over claim 1-27 of ‘959 in view of Huang, claims 1 and 9-10 of the instant application is not patentably distinct from claims 1-27 of ‘959.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 8, and 16-17 of U.S. Patent No. 9,944,598 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘598 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘598’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).
A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claim 1 in the instant application would have been obvious over claims 3, 8, and 16-17 of ‘598 in view of Huang, claim 1 of the instant application is not patentably distinct from claim 3, 8, and 16-17 of ‘598.
Claims 1-8, 11-12, and 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 8 of U.S. Patent No. 10,206,902 B2 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘902 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘902’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).
A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claim 1 in the instant application would have been obvious over claims 3 and 8 of ‘902 in view of Huang, claim 1 of the instant application is not patentably distinct from claims 3 and 8 of ‘902.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 10,765,662 B2 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘662 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘662’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).
A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claim 1 in the instant application would have been obvious over claim 3 of ‘662 in view of Huang, claim 1 of the instant application is not patentably distinct from claim 3 of ‘662.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 4 of U.S. Patent No. 10,689,340 B2 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘340 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘340’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).
A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claim 1 in the instant application would have been obvious over claims 2 and 4 of ‘340 in view of Huang, claim 1 of the instant application is not patentably distinct from claims 2 and 4 of ‘340.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 10,029,984 B2 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘984 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘984’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).
A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claim 1 in the instant application would have been obvious over claim 3 of ‘984 in view of Huang, claim 1 of the instant application is not patentably distinct from claim 3 of ‘984.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11,773,126 B2 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘126 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘126’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).
A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claim 1 in the instant application would have been obvious over claim 3 of ‘126 in view of Huang, claim 1 of the instant application is not patentably distinct from claim 3 of ‘126.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 10,786,484 B2 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘484 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘484’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).
A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claim 1 in the instant application would have been obvious over claim 3 of ‘484 in view of Huang, claim 1 of the instant application is not patentably distinct from claim 3 of ‘484.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 5 of U.S. Patent No. 10,646,469 B2 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘469 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘469’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).
A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claim 1 in the instant application would have been obvious over claims 3 and 5 of ‘469 in view of Huang, claim 1 of the instant application is not patentably distinct from claims 3 and 5 of ‘469.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11,179,368 B2 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘368 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘368’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).
A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claim 1 in the instant application would have been obvious over claim 5 of ‘368 in view of Huang, claim 1 of the instant application is not patentably distinct from claim 5 of ‘368.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,053,196 B2 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘196 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘196’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).
A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claim 1 in the instant application would have been obvious over claim 6 of ‘196 in view of Huang, claim 1 of the instant application is not patentably distinct from claim 6 of ‘196.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11,702,387 B2 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘387 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘387’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).
A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claim 1 in the instant application would have been obvious over claim 3 of ‘387 in view of Huang, claim 1 of the instant application is not patentably distinct from claim 3 of ‘387.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11,083,707 B2 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘707 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘707’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claim 1 in the instant application would have been obvious over claim 5 of ‘707 in view of Huang, claim 1 of the instant application is not patentably distinct from claim 5 of ‘707.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 10 of U.S. Patent No. 10,913,716 B2 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘716 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘715’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).
A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claim 1 in the instant application would have been obvious over claims 2 and 10 of ‘716 in view of Huang, claim 1 of the instant application is not patentably distinct from claims 2 and 10 of ‘716.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 10,730,884 B2 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘884 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘884’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).
A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claim 1 in the instant application would have been obvious over claim 3 of ‘884 in view of Huang, claim 1 of the instant application is not patentably distinct from claim 3 of ‘884.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 11,407,715 B2 in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
‘715 claims a pharmaceutical composition comprising a dengue viral replication inhibitor and one or more pharmaceutically acceptable excipients, diluents, or carriers.
‘715’s claims do not recite that the pharmaceutically excipients, diluents, or carriers are either a methacrylic acid copolymer or a cellulose derivative.
Huang teaches various strategies by which API solubility can be improved, mentioning cellulose derivatives (p. 12, Lines 22-30) and methacrylic acid copolymers (p. 12, Lines 31-35 – p. 13, Lines 1-9).
A PHOSITA would have had a reasonable expectation of success in selecting to include a cellulose derivative or a methacrylic acid copolymer in a pharmaceutical composition containing a dengue viral replication inhibitor because Huang teaches these additional components can lead to advantageous pharmaceutical properties in the composition. Thus, a skilled artisan would have been motivated to include a cellulose derivative and/or a methacrylic acid copolymer in a pharmaceutical formulation containing an API. Because claim 1 in the instant application would have been obvious over claim 10 of ‘715 in view of Huang, claim 1 of the instant application is not patentably distinct from claim 10 of ‘715.
Conclusion
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/B.L.B./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623