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
Claims 37, 38 an 57-60 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 January 22, 2026.
Claims 1, 5, 15-23 and 54-56 are examined on the merits.
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.
US 12048768 B2
Claims 1, 5, 15-21, 54-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12048768 B2.
The present claim 54 is directed to a gastro-resistant, controlled release dosage form, comprising:
about 19 to about 29% w/w 1H-isoindol-1-one, 2-[[1-[2-(4-fluorophenyl)-2-oxoethyl]-4-piperidinyl]methyl]-2,3-dihydro-, hydrochloride, hydrate (1:1:2) (roluperidone hydrochloride);
about 4 to about 14% w/w of a first hypromellose;
about 17 to about 27% w/w of a second hypromellose;
about 19 to about 29% w/w of a first filler;
about 8 to about 18% w/w of a second filler;
about 0.1 to about 4% w/w of a glidant;
about 0.1 to about 4% of a lubricant;
about 1 to about 10% w/w of a polymeric controlled release agent; and
about 0.5 to about 5% w/w of an anti-tacking agent.
The reference claim 1 discloses a gastro-resistant, controlled release dosage form comprising:
about 7 to about 17% w/w 1H-isoindol-1-one, 2-[[1-[2-(4-fluorophenyl)-2-oxoethyl]-4-piperidinyl]methyl]-2,3-dihydro-, hydrochloride, hydrate (1:1:2) (roluperidone hydrochloride);
about 4 to about 14% w/w of a sustained release usage grade hypromellose;
about 17 to about 27% w/w of a controlled-release grade hypromellose,;
about 25 to about 35% w/w microcrystalline cellulose, which meets the first filler;
about 13 to about 23% w/w lactose monohydrate, which meets the second filler;
about 0.1 to about 4% w/w silica colloidal anhydrous, which is a glidant;
about 0.1 to about 4% magnesium stearate, which is a lubricant;
about 1 to about 10% w/w methacrylic acid and ethyl acrylate copolymer dispersion, which is a enteric release agent; and
about 0.5 to about 5% w/w of an anti-tacking agent.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims teach a controlled release dosage form comprising the same active ingredient and excipients in overlapping amounts. See the present claims 54-56.
Claim 1 is directed to a gastro-resistant, controlled release dosage form comprising:
i. about 4 mg to about 100 mg of Compound (I), or an equivalent amount of a pharmaceutically acceptable salt and/or solvate thereof; and
ii. at least one controlled release agent;
wherein the dosage form is a tablet comprising a core and an enteric coating.
The reference claim 1 discloses a gastro-resistant, controlled release dosage form, comprising:
about 19 to about 29% w/w 1H-isoindol-1-one, 2-[[1-[2-(4-fluorophenyl)-2-oxoethyl]-4-piperidinyl]methyl]-2,3-dihydro-, hydrochloride, hydrate (1:1:2) (roluperidone hydrochloride), which is the salt of Compound (I);
about 4 to about 14% w/w of a low-viscosity, controlled-release grade hypromellose, that is about 19 to about 24% methoxy, about 7 to about 12% hydroxypropoxy, and wherein the hypromellose has a viscosity of about 80 to about 120 mPa·s at 2% concentration in water at 20° C., which meets the at east one controlled release agent;
about 1 to about 10% w/w methacrylic acid and ethyl acrylate copolymer dispersion, which is an entering agent.
The term “controlled release dosage form” in the reference claim is defined to include a tablet which comprises a core tablet and an enteric coating.
Although the reference claims do not disclose the specific mass of the active ingredient, the term “controlled release dosage form” is also defined to include an embodiment comprising Compound (I), wherein the amount of Compound (I) is 4 mg to 8 mg, 8 mg to 16 mg, 16mg to 32mg, 32mg to 40 mg, 40mg to 64mg, 64 mg to 80mg, or 80-mg to 100mg. See Table 1 also defines a controlled release tablet comprising 12.09 % w/w of the Compound (I) to contain 38.40 mg of the compound per tablet.
Thus, although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims teach a controlled release dosage form comprising the same active ingredient and excipients in overlapping amounts. See the present claims 1 and 5.
Regarding claims 15-18, 20, 21 the gastro-resistant, controlled release dosage form of the disclosed claim 1 is also defined to include a core tablet comprising Compound (I), a controlled release agent (hypromellose), a filler (microcrystalline cellulose, etc), a glidant (silica colloidal anhydrous) and a lubricant (magnesium stearate). See Table 2; the reference claim 1.
Regarding claim 19, the reference claim 1 also discloses that a gastro-resistant controlled release dosage form comprising Compound (I) has a mixture of
(i)about 4 to about 14% w/w of a controlled-release grade hypromellose, that is about 22 to about 24% methoxy, about 8 to about 10.5% hydroxypropoxy, and wherein the hypromellose has a viscosity of about 80-120 mPa·s at 2% concentration in water at 20° C.;
about 17 to about 27% w/w of a controlled-release grade hypromellose, that is about 19 to about 24% methoxy, about 7 to about 12% hydroxypropoxy, and wherein the hypromellose has a viscosity of about 80,000 to about 120,000 mPa·s at 2% concentration in water at 20° C.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over US Pat No. 12048768 as applied to claims 1, 5, 15-21 and 54-56 above, and as evidenced by Evonik Operations (“Functional excipients to take control of your release profile”, Evonik Operations GMBH, May 2024) (“Evonik I” hereunder).
Regarding claim 22, the reference claim 1 discloses methacrylic acid and ethyl acrylate copolymer dispersion and an anti-caking agent. The “methacrylic acid and ethyl acrylate copolymer dispersion” is defined as Eudragit L30D55. See Table 2. Evonik I teaches that Eudragit L30D55, is inherently soluble above pH 5.5.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over US Pat No. 12048768 as applied to claims 1, 5, 15-21 and 54-56 above, and further in view of Evonik Industries (Eudragit L30 D-55, Technical Information-Quickstart, Evonik Industries AG, December 2011) (“Evonik II” hereunder).
Regarding claim 23, although the reference claims do not specifically disclose a plasticizer, Evonik II teaches that Eudragit L30D55 is used as enteric coating and used with a plasticizer and an anti-tacking agent. See Evonik II, p. 1, Formulation. The reference goes on to teach examples of how to apply the film coating on tablets or particles. See p. 2. It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to use the enteric coating polymer with a plasticizer as motivated by Evonik II with a reasonable expectation to increase plasticity of the film.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GINA JUSTICE whose telephone number is (571)272-8605. The examiner can normally be reached M-F 9:00 AM - 5 PM.
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/GINA C JUSTICE/Primary Examiner, Art Unit 1617
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