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 .
Claim Status
Claims 1-20 are pending. Claims 1-20 are rejected.
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.
Claim(s) 1-16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017023714 A1 by Harris et al. (Cited in the IDS filed 10/22/2024)
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Harris et al. teach (title) “Fixed-dose Combinations of Antiviral Compounds”. Regarding instant claims 1 and 9, Harris et al. disclose instant Compound A as Compound II in a blended composition formulated as a tablet, and wherein the prior art compound is substantially amorphous (page 6, lines 12-21; page 26, line 19; claim 2). Regarding the limitation wherein the tablet does not contain an ionic salt, further discloses that the salt may be present in a concentration of about 0%w/w, therefore absent (page 25, lines 4-10).
Harris et al. disclose the instant methods of preparation and state “[t]he blended compositions may be roller compacted or wet granulated to density and/or reduce the risk of segregation of components during subsequent handling (e.g. , compression into tablets)” as required by instant claims 1 and 9 (page 28, lines 6-8).
Harris et al. disclose the prior art composition comprising instant compound A and a polymer wherein instant compound A is present in a concentration of about 5%w/w to about 50%w/w, corresponding to instant claims 3 and 11 (page 13, lines 24-28).
Regarding instant claims 2 and 10, the prior art teaches the composition wherein the instant compound A is spray-dried. Harris et al. explain (page 16, line 31- page 17, line 5):
The first solid dispersion formulation described herein relates to solid dispersion formulations produced by solvent removal (e.g., spray drying), introduction of an antisolvent (e.g., precipitation), addition of heat together with mixing (e.g. , extrusion), mechanical activation or other means (e.g. , to produce a "solid dispersion intermediate"). That is, the solid dispersion formulation may be formed by a process selected from spray drying and extrusion, such as hot melt extrusion, of the composition. In particular instances, the solid dispersion formulation comprises particles of the composition formed by spray drying.
Harris et al. disclose suitable diluents including mannitol and microcrystalline cellulose and specify a concentration of about 3%w/w to about 58%w/w, in accordance with instant claims 4 and 12 (page 24, lines 21-26).
The prior art discloses croscarmellose sodium as a disintegrant and notes that it may be present in a concentration of about 4%w/w to about 20%w/w, corresponding to instant claims 5 and 13 (page 24, line 30- page 25, line 2).
Regarding instant claims 6 and 14, Harris et al. disclose magnesium stearate as a suitable lubricant in a concentration of about 0.5%w/w to about 4%w/w (page 25, lines 12-17).
Harris et al. disclose suitable glidants including talc, magnesium stearate, etc. and specify a concentration of about 0%w/w to about 2%w/w, in accordance with instant claims 7 and 15 (page 25, lines 19-23).
The prior art discloses TPGS, poloxamer, etc. as surfactants and notes that surfactants may be present in a concentration of about 2%w/w to about 20%w/w, corresponding to instant claims 8 and 16 (page 22, lines 8-14).
Regarding instant claims 19 and 20, Harris et al. teach the prior art combination wherein the pharmaceutically acceptable polymer is hydroxypropylmethyl cellulose (HPMC), hydroxypropylmethyl cellulose acetate succinate (HPMCAS), etc. and present in a concentration of about 50%w/w to about 95%w/w (page 15, lines 2-9).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art discloses each of the components required for instant claims 1-16 and 19-20 but does not teach an explicit embodiment that anticipates the claims.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
A person having ordinary skill in the art in seeking to optimize the pharmaceutical compositions would have been motivated to test the formulations and formulating agents taught by the prior art.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017023714 A1 by Harris et al. as applied to claims 1-16 and 19-20 above, and further in view of Surfactants: Pharmaceutical and Medicinal Aspects. J. Pharm. Technol. Res. Manag. 2013, 01, 43-68 by Sekhon et al. (cited in the IDS filed 10/22/2024).
The prior art discloses instant Compound A, dimethyl((2S,2'S)-((2S,2'S)-2,2'-(5,5'-((S)-6-(2-cyclopropylthiazol-5-yl)-1-fluoro-6H-benzo[5,6][1,3]oxazino[3,4-a]indole-3,10-diyl)bis(1H-imidazole-5,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl))dicarbamate, in a tablet comprising a pharmaceutical formulation prepared by wet-granulation; however, the prior art does not specifically disclose wetting agents or solubilizers required by the instant claims.
Sekhon teaches (title) “Surfactants: Pharmaceutical and Medicinal Aspects”. Regarding non-ionic surfactants and their uses, the prior art teaches (page 46, paragraph 2, Non-ionic surfactants):
[t]he non-ionic surfactant can be classified as polyol esters, polyoxyethylene esters, poloxamers. polyol esters includes glycol and glycerol esters and sorbitan derivatives. Fatty acid esters of sorbitan (generally referred to as Spans) and their ethoxylated derivatives (generally referred to as Tweens) are perhaps one of the most commonly used non-ionics.
Further (page 47, paragraph 1):
[t]he most commonly used non-ionic surfactants are ethers of fatty alcohols (Zhang et al., 2009). The Sorbitan esters are insoluble in water, but soluble in most organic solvents (low hydrophile–lipophile balance (HLB) value and are used as water-in-oil emulsifiers and as wetting agents. The ethoxylated products are generally soluble in water and have relatively high HLB numbers ((greater than about 12). The nonionic surfactants products mainly serve as emulsifier, wetter, solubilizer and dispersant in pharmaceutical industry.
Accordingly, one of ordinary skill in the art would be motivated to use any of the non-ionic surfactants commonly disclosed by Sekhon and Harris et al. as wetting agents and/or solubilizers, in accordance with instant claims 17 and 18, to improve the performance of the disintegration systems for pharmaceutical dosage forms taught by Harris et al. Additionally, Harris et al. disclose the use of said surfactants in concentrations from about 2% w/w to about 20% w/w (page 22, lines 8-14); the overlapping range taught by the prior art renders obvious the instant claims.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 9,555,038 in view of WO 2017023714 A1 by Harris et al. and Surfactants: Pharmaceutical and Medicinal Aspects. J. Pharm. Technol. Res. Manag. 2013, 01, 43-68 by Sekhon et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 5 of the patent is generic to a pharmaceutical composition comprising instant compound A. The instantly claimed tablet would have been an obvious embodiment of the patent claims for the same reasons as discussed under 35 USC 103 relative to claims 1-20. The teachings of Harris et al. and Sekhon et al. relative to claims 1-20 are incorporated here by reference.
Conclusion
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/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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