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 .
Election/Restrictions
Applicant’s election without traverse of invention group I, claims 44-59, in the reply filed on 007/02/2026 is acknowledged.
Claims 60-63 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/02/2026.
Claims 44-63 are pending, claims 44-59 are under examination.
Priority
Acknowledge is made that this application is a national stage of International Application No. PCT/US2022/047769. filed October 25, 2022, which claims the benefit under 35 U.S.C. §119(e) of US Provisional Application No. 63/271,977, filed October 26, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/18/2024 and 12/09/2024 is being considered by the examiner.
Claim Rejections - 35 USC § 112
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 47, 48, 51, 54, 55, 56, 57, 58 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 47 recites the broad recitation about 20% to about 50%, and the claim also recites about 20% to about 40% or about 20% to about 30%; which is the narrower statement of the range/limitation.
In the present instance, claim 48 recites the broad recitation great than about 50%, and the claim also recites about 60% to about 80%, which is the narrower statement of the range/limitation.
In the present instance, claim 51 recites the broad recitation about 40%-70%, and the claim also recites about 60%, which is the narrower statement of the range/limitation.
In the present instance, claim 54 recites the broad recitation about 1:1 to about 1:5, and the claim also recites about 1:2 to about 1:4 and about 1:3, which is the narrower statement of the range/limitation.
In the present instance, claim 55 recites the broad recitation about 1:1 to about 1:5, and the claim also recites about 1:2 to about 1:4 and about 1:3, which is the narrower statement of the range/limitation.
In the present instance, claim 56 recites the broad recitation substantially amorphous and the claim also recites at least 98% is in an amorphous form, which is the narrower statement of the range/limitation.
In the present instance, claim 57 recites the broad recitation free base or a solvate, and the claim also recites free base hydrate and free base monohydrate, which is the narrower statement of the range/limitation.
In the present instance, claim 58 recites the broad recitation free base or a solvate, and the claim also recites free base hydrate and free base monohydrate, which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 54, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 47-48, 51, 54-55, 57-58, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 47, 48, 51, 54, 55, 57, 58 cite parenthesis, and it is unclear if the subject matter contained within the parenthesis is further limiting or not. A parenthetical expression is simply a word or string of words which contains relevant yet non-essential information and are non-restrictive which means that the phrase may be removed from the sentence without changing the meaning of the sentence. Parenthetical expressions are not permissible which do not contribute to clearness or exactness in stating Applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 44 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Reader et al. (WO2018193410).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Reader et al. teaches the compound (2R)-2-(6-{5-chloro-2-[ ( oxan-4-yl)amino ]pyrimidin-4-yl}-1-oxo-2,3-dihydro-1 H-isoindol-2-yl)-N-[( 1 S)-1-(3-fluoro-5-methoxyphenyl)-2-hydroxyethyl]propanamide which has the formula (1) (page 3, line 25-30). The compound can be crystalline or amorphous and free base or salt (page 4, line 10-15; page 14, line 5-10; page 77, line 15-25).
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The compound of formula (1) has relatively poor solubility in water (page 19, line 15). The composition comprising compound of formula (1) is a tablet compositions that can contain a unit dosage of active compound together with an inert diluent or carrier such as a sugar or sugar alcohol, eg; lactose, sucrose, sorbitol or mannitol; and/or a non-sugar derived diluent such as sodium carbonate, calcium phosphate, calcium carbonate, or a cellulose or derivative thereof such as microcrystalline cellulose (MCC), methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose, and starches such as corn starch. Tablets may also contain such standard ingredients as binding and granulating agents such as polyvinylpyrrolidone, disintegrants (e.g. swellable crosslinked polymers such as crosslinked carboxymethylcellulose), lubricating agents (e.g. stearates), preservatives (e.g. parabens), antioxidants (e.g. BHT), buffering agents (for example phosphate or citrate buffers), and effervescent agents such as citrate/bicarbonate mixtures. Such excipients are well known and do not need to be discussed in detail here (page 49, line 4-15). The pharmaceutical compositions may comprise from approximately 1 % (w/w) to approximately 95% active ingredient and from 99% (w/w) to 5% (w/w) of a pharmaceutically acceptable excipient or combination of excipients (page 50, line 15-20). Pharmaceutical compositions for oral administration can be obtained by combining the active ingredient with solid carriers, if desired granulating a resulting mixture, and processing the mixture, if desired or necessary, after the addition of appropriate excipients, into tablets, dragee cores or capsules. It is also possible for them to be incorporated into a polymer or waxy matrix
that allow the active ingredients to diffuse or be released in measured amounts.
The compound of the invention can also be formulated as solid dispersions. Solid dispersions are homogeneous extremely fine disperse phases of two or more solids. Solid solutions (molecularly disperse systems), one type of solid dispersion, are well known for use in pharmaceutical technology (see Chiou and Riegelman, J. Pharm. Sci., 60, 1281-1300 (1971)) and are useful in increasing dissolution rates and increasing the bioavailability of poorly water soluble drugs. The invention also provides solid dosage forms comprising the solid solution described above. Solid dosage forms include tablets, capsules and chewable tablets, or dispersible or effervescent tablets. Known excipients can be blended with the solid solution to provide the desired dosage form. A tablet can contain the solid solution blended with at least one disintegrant, a lubricant, a surfactant, a bulking agent and a glidant. A chewable tablet can contain the solid solution blended with a bulking agent, a lubricant, and if desired an additional sweetening agent (such as an artificial sweetener), and suitable flavours. Solid solutions may also be formed by spraying solutions of drug and a suitable polymer onto the surface of inert carriers such as sugar beads ('non-pareils'). These beads can subsequently be filled into capsules or compressed into tablets (page 51, line 5-30). The compressed tablet may be optionally film coated (page 91, line 25-26).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Reader et al. is that Reader et al. is not specific enough for anticipation.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the instant invention.
Reader et al. teaches a pharmaceutical composition comprising a compound of formula (1) (applicant’s claimed compound I) and hydropxypropylmethyl cellulose; and compound of formula (1) is free base in one embodiment.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that 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 was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 45-56 and 58-59 are rejected under 35 U.S.C. 103 as being unpatentable over Reader et al. (WO2018193410), as applied for the above 103 rejection for claim 44 and 57, in view of Nair et al. (“Overview of Extensively Employed Polymeric Carriers In Solid Dispersion Technology”, AAPS PharmSciTech (2020) 21, 309; cited in IDS), Jain et al. (US20200222395) and Shahar et al. (US20160199396).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Reader et al. teaching has already been discussed in the above 103 rejection and is incorporated herein by reference.
Nair et al. teaches Solid dispersion is the preferred technology to prepare efficacious forms of BCS class-II/IVAPIs. To prepare solid dispersions, there exist a wide variety of polymeric carriers with interesting physicochemical and thermochemical characteristics available at the disposal of a formulation scientist. Since the advent of the solid dispersion technology in the early 1960s, there have been more than 5000 scientific papers published in the subject area. This review discusses the polymeric carrier properties of most extensively used polymers PVP, Copovidone, PEG, HPMC, HPMCAS, and Soluplus® in the solid dispersion technology (abstract). HYDROXY PROPYL METHYL CELLULOSE ACETATE SUCCINATE (HPMCAS) is suitable polymer for solid dispersion (page 11).
Jain et al. teaches Solid dispersions of lurasidone or a pharmaceutically acceptable salt thereof are described, as well as pharmaceutical formulations thereof, and methods for making such formulations. Preferably, the solid dispersions are prepared by hot-melt extrusion or spray-drying, and comprise lurasidone with a pharmaceutically acceptable carrier (e.g., hydroxypropyl methyl cellulose acetate succinate (HPMC-AS), polyvinyl pyrrolidine vinyl acetate (PVP/VA) copolymer, hydroxypropyl methylcellulose phthalate (HPMCP), or mixtures thereof) (abstract). Lurasidone is very slightly soluble in water ([0006]). A pharmaceutical composition as described herein, wherein the pharmaceutical composition comprises granules of the solid dispersion of amorphous lurasidone, and further comprising at least one extra-granular excipient selected from the group consisting of microcrystalline cellulose, croscarmellose sodium (Ac-Di-Sol), colloidal silicon dioxide, and mixtures thereof; preferably wherein the at least one extra-granular excipient comprises microcrystalline cellulose, croscarmellose sodium (Ac-Di-Sol), or mixtures thereof. More preferably, the at least one extra-granular excipient consists essentially of, or consists of, microcrystalline cellulose, croscarmellose sodium (Ac-Di-Sol), and colloidal silicon dioxide and/or the at least one extra-granular excipient consists essentially of, or consists of, microcrystalline cellulose and croscarmellose sodium (Ac-Di-Sol). A pharmaceutical composition as described herein, wherein the pharmaceutical composition comprises granules of the solid dispersion of amorphous lurasidone, and wherein the granules further comprise at least one intra-granular excipient, preferably wherein the at least one intra-granular excipient comprises microcrystalline cellulose, croscarmellose sodium (Ac-Di-Sol), colloidal silicon dioxide, or mixtures thereof. Preferably, the at least one intra-granular excipient consists essentially of, or consists of microcrystalline cellulose, croscarmellose sodium (Ac-Di-Sol), and colloidal silicon dioxide ([0032-0033]). In an embodiment, a lurasidone solid dispersion of the present application comprises lurasidone and a pharmaceutically acceptable polymer, wherein lurasidone and polymer are in the ratio of about 1:1 to about 1:4 (w/w) ([0101]). The lurasidone in the solid dispersion obtained may be present in either crystalline or amorphous powder form. In some aspects herein, the percentage loading of lurasidone in the solid dispersion is from about 1% to about 90% (w/w) ([0109-0110]). The lurasidone solid dispersion may be combined with pharmaceutically acceptable excipients to make other pharmaceutical compositions, or a finished dosage form. The one or more additional pharmaceutically acceptable excipients are selected from diluents, binders, disintegrants, fillers, lubricants, glidants, surfactants, stabilizing agents, antioxidants, alkaline stabilizers, colors, flavors, preservatives, and combinations thereof ([0131]). In an embodiment, pharmaceutical compositions comprising lurasidone solid dispersion and pharmaceutically acceptable excipients are prepared by using direct compaction dry granulation, which process comprises compressing mixture of lurasidone solid dispersion and intragranular material into slug, compressed slugs are milled and passed through mess screen manually or automatically which results in granules. The resulting granules were mixed with extra granular material. This final mixture is either compressed to tablet or filled in hard gelatin capsules ([0135]). The pharmaceutical compositions of the present invention include one or more diluents. In an embodiment, suitable diluents include microcrystalline cellulose, calcium carbonate, calcium phosphate-dibasic, calcium phosphate-tribasic, calcium sulfate, cellulose powdered, dextrates, dextrins, dextrose excipients, fructose, kaolin, lactitol, lactose, mannitol, sorbitol, starch, starch pregelatinized, sucrose, sugar compressible, sugar confectioners and the like. In an embodiment, diluent is included either in intragranular material or extra granular material or both. In an embodiment, the diluent concentration in the intragranular material ranges from about 10% to about 60% w/w of total composition, preferably about 25% to about 35%, more preferably about 27% w/w. In an embodiment, the diluent concentration in the extra granular material ranges from about 10% to about 60% w/w of total composition, preferably about 25% to about 35%, more preferably about 28% w/w ([0138-0142]). In an embodiment, suitable binders include methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyvinyl pyrrolidone, microcrystalline cellulose, gelatin, gum arabic, ethyl cellulose, polyvinyl alcohol, pullulan, pregelatinized starch, agar, tragacanth, sodium alginate, propylene glycol and the like. In an embodiment, the binder concentration ranges from about 10% to about 60% w/w of total composition, preferably about 25% to about 35% w/w ([0143-0144]). In an embodiment, suitable disintegrating agents include croscarmellose sodium, low-substituted hydroxypropyl cellulose (L-HPC), sodium starch glycollate, carboxymethyl cellulose, calcium carboxymethyl cellulose, sodium carboxymethyl cellulose, starch, crystalline cellulose, hydroxypropyl starch, pregelatinized starch, and the like and mixtures thereof. In an embodiment, the disintegrating agent concentration ranges from about 1% to about 10% w/w of total composition ([0145-0146]). In an embodiment, suitable lubricants/glidants include colloidal silicon dioxide, stearic acid, magnesium stearate, calcium stearate, talc, hydrogenated castor oil, sucrose esters of fatty acid, microcrystalline wax, yellow beeswax, white beeswax, and the like and mixtures thereof. In an embodiment, the lubricants/glidants concentration ranges from about 0.5% to about 5% w/w of total composition ([0147-0148]).
Shahar et al. teaches A monolithic tablet according to any of Paragraphs 45D-48D, wherein the glidant is selected from one or more of the group consisting of colloidal silica, silica gel, precipitated silica or talc, and the like or any combinations thereof ([0606]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Reader et al. is that Reader et al. do not expressly teach hydroxypropyl methyl cellulose acetate succinate, tablet with intra-granular layer and extra-granular layer as well as ingredients. This deficiency in Reader et al. is cured by the teachings of Nair et al., Jain et al. and Shahar et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Reader et al., as suggested by Nair et al., Jain et al. and Shahar et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to prepare solid dispersion of compound I in hydroxypropyl methyl cellulose acetate succinate because hydroxypropyl methyl cellulose acetate succinate is a suitable polymeric carrier for solid dispersion. MPEP 2144.07. Under guidance from Reader et al. teaching solid dispersion of compound I, Nair et al. teaching hydroxypropyl methyl cellulose acetate succinate as polymer carrier for solid dispersion, Jain et al. teaches hydroxypropyl methyl cellulose acetate succinate as carrier for poor aqueous soluble compound in solid dispersion, it is obvious for one of ordinary skill in the art to prepare solid dispersion of compound I in hydroxypropyl methyl cellulose acetate succinate and produce instant claimed invention with reasonable expectation of success.
Regarding claims 45-46, prior art teaches a solid dispersion comprising compound I molecularly dispersed in hydroxypropyl methyl cellulose acetate succinate.
Regarding claims 47-48 and 54-55, Jain et al. teaches active agent about 1% to about 90% in dispersion and active agent to polymer HPMCAS ratio 1:3; thus, when active agent is 20%, the polymer HPMCAS is 60%.
Regarding claims 49-50, Reader et al. teaches tablet and film coating; Jain et al. teaches tablet.
Regarding claims 51 and solid dispersion amount in claim 59, Reader et al. teaches 1 % - 95% active ingredient in the composition, since the solid dispersion comprises 20% of active agent and 60% of HPMCAS as discussed for claims 47-48, when the active agent is 12% in the tablet (whole composition), the solid dispersion is 60% in the tablet so that the active agent is 60%x20%=12% in the tablet.
Regarding claim 52, one of ordinary skill in the art would have been motivated to prepare a tablet comprising intra-granular layer comprising solid dispersion of active agent and suitable excipients, and extra-granular layer comprising suitable excipients because this is a suitable tablet formulation as suggested by Jain et al. MPEP 2144.07. therefore, it is obvious for one of ordinary skill in the art to prepare a tablet comprising intra-granular layer comprising solid dispersion of active agent and suitable excipients, and extra-granular layer comprising suitable excipients and produce instant claimed invention with reasonable expectation of success.
Regarding intra-granular layer in claims 53 and 59, Jain et al. teaches 10%-60% of biner microcrystalline cellulose, about 10% to about 60% diluent lactose (obvious variant to lactose monohydrate), about 1-10% disintegrating agent croscarmellose sodium; about 0.5% to about 5% w/w of glidant such as magnesium stearate and the like and mixture (because Jain et al. teaches colloidal silicon dioxide (glidant) as intra-granular excipient), under guidance from Shahar et al. teaching precipitated silica as glidant in tablet, it is obvious to have the mixture of precipitated silica and magnesium stearate at 0.5% to 5% as glidant in the intra-granular layer. Therefore, the 0.5%-2% of precipitated silica and 0.1%-0.5% of magnesium stearate is obvious since their combined amount is in the range of 0.5%-5%. Precipitated silica is considered non-fumed silica.
Regarding extra-granular portion in claims 53 and 59, Jain et al. teaches about 1-10% disintegrating agent croscarmellose sodium; about 0.5% to about 5% w/w of glidant such as magnesium stearate and the like and mixture (because Jain et al. teaches colloidal silicon dioxide (glidant) as extra-granular excipient), under guidance from Shahar et al. teaching precipitated silica as glidant in tablet, it is obvious to have the mixture of precipitated silica and magnesium stearate at 0.5% to 5% as glidant in the extra-granular layer. Therefore, the 0.5%-2% of precipitated silica and 0.1%-0.5% of magnesium stearate is obvious since their combined amount is in the range of 0.5%-5%. Precipitated silica is considered non-fumed silica.
Regarding claim 56, both Reader et al. and Jain et al. teaches amorphous.
Regarding claim 58, Reader et al. teaches free base, and there is no requirement to have salt of active agent for solid dispersion.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that 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 was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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 44-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 10457669 in view of Reader et al. (WO2018193410), Nair et al. (“Overview of Extensively Employed Polymeric Carriers In Solid Dispersion Technology”, AAPS PharmSciTech (2020) 21, 309; cited in IDS), Jain et al. (US20200222395) and Shahar et al. (US20160199396). The reference patent teaches (2R)-2-(6-{5-chloro-2-[ ( oxan-4-yl)amino ]pyrimidin-4-yl}-1-oxo-2,3-dihydro-1 H-isoindol-2-yl)-N-[( 1 S)-1-(3-fluoro-5-methoxyphenyl)-2-hydroxyethyl]propenamide (applicant’s claimed compound I) but silent about solid dispersion, HPMCAS as well as intragranular and extra-granular excipients, in view of Reader et al. teaches solid dispersion comprising compound I, Nair et al., Jain et al. and Shahar et al. teaching solid dispersion with HPMCSA as well as intragranular and extra-granular excipients, it is obvious to produce applicant’s claimed invention with reasonable expectation of success.
Claims 44-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 11001575 in view of Reader et al. (WO2018193410), Nair et al. (“Overview of Extensively Employed Polymeric Carriers In Solid Dispersion Technology”, AAPS PharmSciTech (2020) 21, 309; cited in IDS), Jain et al. (US20200222395) and Shahar et al. (US20160199396). The reference patent teaches (2R)-2-(6-{5-chloro-2-[ ( oxan-4-yl)amino ]pyrimidin-4-yl}-1-oxo-2,3-dihydro-1 H-isoindol-2-yl)-N-[( 1 S)-1-(3-fluoro-5-methoxyphenyl)-2-hydroxyethyl]propenamide (applicant’s claimed compound I) but silent about solid dispersion, HPMCAS as well as intragranular and extra-granular excipients, in view of Reader et al. teaches solid dispersion comprising compound I, Nair et al., Jain et al. and Shahar et al. teaching solid dispersion with HPMCSA as well as intragranular and extra-granular excipients, it is obvious to produce applicant’s claimed invention with reasonable expectation of success.
Claims 44-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 20 of U.S. Patent No. 11939321 in view of Reader et al. (WO2018193410), Nair et al. (“Overview of Extensively Employed Polymeric Carriers In Solid Dispersion Technology”, AAPS PharmSciTech (2020) 21, 309; cited in IDS), Jain et al. (US20200222395) and Shahar et al. (US20160199396). The reference patent teaches (2R)-2-(6-{5-chloro-2-[ ( oxan-4-yl)amino ]pyrimidin-4-yl}-1-oxo-2,3-dihydro-1 H-isoindol-2-yl)-N-[( 1 S)-1-(3-fluoro-5-methoxyphenyl)-2-hydroxyethyl]propenamide (applicant’s claimed compound I) but silent about solid dispersion, HPMCAS as well as intragranular and extra-granular excipients, in view of Reader et al. teaches solid dispersion comprising compound I, Nair et al., Jain et al. and Shahar et al. teaching solid dispersion with HPMCSA as well as intragranular and extra-granular excipients, it is obvious to produce applicant’s claimed invention with reasonable expectation of success.
Claims 44-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11142518 in view of Reader et al. (WO2018193410), Nair et al. (“Overview of Extensively Employed Polymeric Carriers In Solid Dispersion Technology”, AAPS PharmSciTech (2020) 21, 309; cited in IDS), Jain et al. (US20200222395) and Shahar et al. (US20160199396). The reference patent teaches (2R)-2-(6-{5-chloro-2-[ ( oxan-4-yl)amino ]pyrimidin-4-yl}-1-oxo-2,3-dihydro-1 H-isoindol-2-yl)-N-[( 1 S)-1-(3-fluoro-5-methoxyphenyl)-2-hydroxyethyl]propenamide (applicant’s claimed compound I) but silent about solid dispersion, HPMCAS as well as intragranular and extra-granular excipients, in view of Reader et al. teaches solid dispersion comprising compound I, Nair et al., Jain et al. and Shahar et al. teaching solid dispersion with HPMCSA as well as intragranular and extra-granular excipients, it is obvious to produce applicant’s claimed invention with reasonable expectation of success.
Claims 44-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 12030873 in view of Reader et al. (WO2018193410), Nair et al. (“Overview of Extensively Employed Polymeric Carriers In Solid Dispersion Technology”, AAPS PharmSciTech (2020) 21, 309; cited in IDS), Jain et al. (US20200222395) and Shahar et al. (US20160199396). The reference patent teaches (2R)-2-(6-{5-chloro-2-[ ( oxan-4-yl)amino ]pyrimidin-4-yl}-1-oxo-2,3-dihydro-1 H-isoindol-2-yl)-N-[( 1 S)-1-(3-fluoro-5-methoxyphenyl)-2-hydroxyethyl]propenamide (applicant’s claimed compound I) but silent about solid dispersion, HPMCAS as well as intragranular and extra-granular excipients, in view of Reader et al. teaches solid dispersion comprising compound I, Nair et al., Jain et al. and Shahar et al. teaching solid dispersion with HPMCSA as well as intragranular and extra-granular excipients, it is obvious to produce applicant’s claimed invention with reasonable expectation of success.
Claims 44-59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 18679934 in view of in view of Reader et al. (WO2018193410), Nair et al. (“Overview of Extensively Employed Polymeric Carriers In Solid Dispersion Technology”, AAPS PharmSciTech (2020) 21, 309; cited in IDS), Jain et al. (US20200222395) and Shahar et al. (US20160199396). The reference application teaches (2R)-2-(6-{5-chloro-2-[ ( oxan-4-yl)amino ]pyrimidin-4-yl}-1-oxo-2,3-dihydro-1 H-isoindol-2-yl)-N-[( 1 S)-1-(3-fluoro-5-methoxyphenyl)-2-hydroxyethyl]propenamide (applicant’s claimed compound I) but silent about solid dispersion, HPMCAS as well as intragranular and extra-granular excipients, in view of Reader et al. teaches solid dispersion comprising compound I, Nair et al., Jain et al. and Shahar et al. teaching solid dispersion with HPMCSA as well as intragranular and extra-granular excipients, it is obvious to produce applicant’s claimed invention with reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
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