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 .
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.
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Claims 1-19 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,042,474 (‘474). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘474 patent discloses a dosage form of lacosamide comprising: an extended release (ER) portion comprising one or more extended release agents and a first portion of lacosamide or a pharmaceutically acceptable salt thereof, wherein the first portion of lacosamide or the pharmaceutically acceptable salt thereof and the one or more extended release agents are in a ratio ranging from about 15:1 to about 1:1 by weight, and an immediate release (IR) portion comprising a second portion of lacosamide or a pharmaceutically acceptable salt thereof, wherein the total amount of lacosamide or a pharmaceutically acceptable salt thereof is at least 20% by weight in the dosage form; wherein the dosage form is configured so that, when administered orally once a day, is characterized by one or more of the following: (a) AUC.sub.0-3h is equal or more than 40% of a reference AUC.sub.0-3h resulting from a reference IR dosage form administered twice a day, wherein the amount of lacosamide or a pharmaceutically acceptable salt thereof in the reference IR dosage form is the same as the total amount of lacosamide or a pharmaceutically acceptable salt thereof in the dosage form; (b) AUC.sub.0-6h is equal or more than 60% of a reference AUC.sub.0-6h resulting from the reference IR dosage form administered twice a day; and (c) AUC.sub.12-24h ranging from about 80% to 125% of a reference AUC.sub.12-24h resulting from the reference IR dosage form administered twice a day. See Claim 1. Capsule and tablet dosage forms can be found in claims 12-13. Method of generating a target AUC profile in a subject can be found in claims 18-21.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to obtain the claimed invention given the claims of the ‘474 patent. This is because the ‘474 patent discloses an invention similar to that of the present claims, namely, a dosage form of lacosamide that comprises an extended release portion and an immediate release portion, wherein the total amount of lacosamide or a pharmaceutically acceptable salt thereof is at least 20% by weight in the dosage form, and wherein the dosage form has the claimed pharmacokinetic profile.
Claims 1-19 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,883,374 (‘374). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘374 patent discloses a dosage form of lacosamide or a pharmaceutically acceptable salt thereof, comprising: (a) a first plurality of the particulates, each comprising i. a core comprising lacosamide or a pharmaceutically acceptable salt thereof, and ii. an extended release layer enclosing the core, wherein the extended release layer is free from lacosamide or a pharmaceutically acceptable salt thereof and comprises an extended release agent which is pH independent; wherein the core is free from the extended release agent, and (b) an immediate release portion of lacosamide or a pharmaceutically acceptable salt thereof in the form of a second plurality of particulates, wherein the lacosamide or the pharmaceutically acceptable salt thereof of the immediate release portion ranges from about 5% to about 30% by weigh in the total amount of the lacosamide or the pharmaceutically acceptable salt thereof in the dosage form, wherein the dosage form is configured to have an in-vitro dissolution according to the following: (a) less than about 20% in 1 hour; (b) about 20%-80% in 4 hours; and (c) more than about 80% in 12 hours; wherein the dissolution is determined using a USP type 1 dissolution system (Basket Apparatus) at 100 rpm and a temperature of 37±0.5° C. in 900 ml of pH 6.8 phosphate buffer for 12 hours. See Claim 1. Total amount of lacosamide or a pharmaceutically acceptable salt thereof ranges from about 40% to about 80% by weight in the dosage form is found in Claim 6. Method of treating a neurological or psychiatric disease or condition in a subject is found in Claims 17-19. Method of making the dosage form is found in Claims 15-16.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to obtain the claimed invention given the claims of the copending application. This is because the ‘374 patent discloses an invention similar to that of the present invention, namely, a dosage form of lacosamide that comprises an extended release portion and an immediate release portion, wherein the total amount of lacosamide or a pharmaceutically acceptable salt thereof is within the claimed amount, and wherein the dosage form has the claimed pharmacokinetic profile.
Claims 1-19 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,337,943 (‘943). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘943 discloses a dosage form of lacosamide or a pharmaceutically acceptable salt thereof, comprising: (a) an extended-release portion, comprising: i. a core comprising lacosamide or a pharmaceutically acceptable salt thereof, and ii. an extended release layer enclosing the core, wherein the extended release layer is free from lacosamide or a pharmaceutically acceptable salt thereof and comprises an extended release agent which is pH independent; wherein the core is free from the extended release agent, and (b) an immediate release portion of lacosamide or a pharmaceutically acceptable salt thereof, wherein the lacosamide or a pharmaceutically acceptable salt thereof of the immediate release portion ranges from about 5% to about 30% by weigh in the total amount of lacosamide or a pharmaceutically acceptable salt thereof in the dosage form; wherein the immediate release portion encloses the extended release portion to form a particulate, and wherein the dosage form comprises a plurality of the particulates; wherein the lacosamide or a pharmaceutically acceptable salt thereof in the dosage form has an in-vitro dissolution according to the following: (a) less than about 20% in 1 hour; (b) about 20%-80% in 4 hours; and (c) more than about 80% in 12 hours; wherein the dissolution is determined using a USP type 1 dissolution system (Basket Apparatus) at 100 rpm and a temperature of 37±0.5° C. in 900 ml of pH 6.8 phosphate buffer for 12 hours; wherein the dosage form when orally administered once daily achieves more than 90% of the AUC(0-inf) of an immediate released reference lacosamide administered to the subject in fasting condition, and wherein the daily dosage of the dosage form is the same as the daily dosage of the immediate released reference lacosamide. Lacosamide and extended-release agent in the claimed ratio is found in claim 8. The claimed method is found in claims 16-23.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to obtain the claimed invention given the claims of the ‘943 patent. This is because the ‘943 patent discloses an invention similar to that of the present invention, namely, a once a day extended-release oral dosage form comprising lacosamide and one or more extended-release agents in the claimed ratio.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-19 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaminski et al. US 2018/0021307 A1.
Kaminski teaches an oral composition comprising multiparticulate of active agents coated with a controlled release coating or delayed release matrix. See paragraphs 0085-0089 and 0121. The particulate can be incorporated into tablet or capsule. See paragraphs 0086-0087 and 0119. Active agent including lacosamide is found in the abstract; the claims and throughout the patent. Controlled release agent including cellulosic compounds is found in paragraphs 0091-0095. The amount of the controlled release agent can vary depends on the viscosity of the compound, but can range between 5-30%. See paragraphs 0094-0096. Paragraph 0089 discloses the claimed release profile of wherein less than 45% is released within 1 hour, between 30%-85% is released within 4 hours, and between 70%-100% is released within 12 hours. While Kaminski does not expressly teach the ratio between the active agent and the release retarding agent, Kaminski teaches the composition can comprise between about 10% and 50% active agent and up to 30% of the release retarding agent. See paragraphs 0094-0096 and 0116. From this teaching, it can readily be seen that the ratio between the active agent and the release retarding agent can be at least a 1:1 ratio.
It is noted that the Kaminski reference does not expressly teach the claimed AUC profiles. However, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.). Here, Kaminski teaches the same composition having the same release profiles, therefore, the AUC property is inherent.
Claims 1-19 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prudhvi et al. WO 2011/101863 A2.
Prudhvi teaches an extended release composition of lacosamide comprising particle of lacosamide or its salts coated with a rate-controlling polymer. See abstract. Rate controlling polymer is found in page 6. The claimed release profile is found in page 5 and Examples. Ratio of lacosamide and the rate controlling polymer is found in page 7. Particle of lacosamide filled in capsule is found in page 7. Method for making is found in pages 9-11. Method for treating is found in page 10.
It is noted that the Prudhvi reference does not expressly teach the claimed AUC profiles. However, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.). Here, Prudhvi teaches the same composition having the same release profiles, therefore, the AUC property is inherent.
Claims 1-19 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kulkarni et al. WO 2011055385 A1.
Kulkarni teaches a modified release formulation comprising lacosamide or pharmaceutically acceptable salts, esters, metabolites, prodrugs or enantiomers thereof and modified release polymer. See page 1. The formulation has a release profile such that not more than about 25% of lacosamide is released within 1 hour, from about 30% to about 70% of lacosamide is released within 4 hours, and not less than about 75% of lacosamide is release within 12 hours when tested according to USP type 1 dissolution apparatus at 100 rpm and 37°C temperature in 900 ml of 0.1N HCl. See page 3, lines 15-24 and Example 12. Once a day administration is found in page 5. Lacosamide amount of at least 20%, such as 32.26% is found in the Examples.
While Kulkarni does not teach the claimed AUC, Kulkarni teaches an AUC 0-∞ and a release profile that fall within the claimed range. As such, the claimed pharmacokinetic profiles are inherent because where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.). Here, the Kulkarni reference teaches a formulation similar to that of the present invention, namely, a once a day oral dosage form comprising an extended release portion of lacosamide in an amount of at least 20% based on the total weight of the dosage form, wherein the release rate of lacosamide in the dosage form also falls within the claimed release ranges.
Correspondence
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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