DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The examiner acknowledges receipt of preliminary amendment filed 08/21/2024 and IDS filed 09/12/2024 and 01/14/2025.
Claims 1-69 are canceled.
New claim 170 is added and pending.
Priority
The examiner acknowledges this application as a Continuation of 18/603,884 filed 03/13/2024, now US 12246094 B2; which is a Continuation of 18/475,755 filed 09/27/2023, now US 11964056 B2; which is a Continuation of 18/205,786 filed 06/05/2023, which is a Continuation of 18/143,927 filed 05/05/2023, which is a Continuation of 17 /892,553 filed 08/22/2022 (now pending), which is a Continuation of 16/931,803 filed 07/17/2020, now abandoned, which is a Continuation of 16/697,855 filed 11/27/2019, now abandoned, which is a Continuation of 16/386,963 filed 04/17/2019, now abandoned, which is a Continuation of 15/885,074 filed 01/31,2018, now abandoned, which is a Continuation of 15/597,885 filed 05/17/2017, now abandoned, which is a Continuation of 15/263,932 filed 09/13/2016, now US 9775812 B2, which is a Continuation of 14/729,593 filed 06/03/2015, now US 9486412 B2, which is a Continuation of 14/515,924 filed 10/16/2014, now US 9084816 B2, which is a Continuation of 13/803,132 filed 03/14/2013, now abandoned, which is a Divisional of 11/844,872 filed 08/24/2007, now US 8894987 B2, and which claims benefit of 60/840,244 filed 08/25/2006.
Information Disclosure Statement
The information disclosure statement filed 09/12/2024 and 01/14/2025 have been considered.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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.
Claim 170 is rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11964056 B1 in view of Arkenau-Maric et al. (US 20070048228 Al). Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims teach extended release solid oral tablet (claims 8 and 9) dosage form comprising active agent, one of which is identified as oxycodone/oxycodone hydrochloride (see claims 1, 10-15, 19 and 20), the oxycodone hydrochloride has 14-hydroxycodeinone level of less than about 25 ppm (claim 15), polyethylene oxide (PEO) is present at 30% by weight and having molecular weight of I million Da to 15 million Da (claim 1), 2 million Da to 8 million Da (claim 2) with the 2 million Da to 8 million Da being a specific point range within the claimed rage of 2 million Da to 15 million Da; tablet is a shaped extended release dosage form; and the density of the shaped extended release dosage form is determined by Archimedes Principle using a liquid of known density. While the issued claims are not verbatim as the claimed dosage form, the issued solid extended dosage form teaches the examined solid extended dosage form.
The reference claims are silent with regards to the density of the shaped extended release tablet of the examined claims. However, the claimed density values appear to be an inherent to the ora1 dosage of the reference claims, Notwithstanding, it would also have been obvious to arrive at tablets having densities within the claimed range out of the course of routine optimization, when taken together with the additional teachings of Arkenau-Maric. Arkenau-Maric teaches dosage forms, including those containing oxycodone [0032], and indicate that preferable densities are in particular in the range from 0.95 to L25 g/cm 3 [0040]. Arkenau-Maric also indicates that density can be altered by experirnenta1 conditions including increasing volume, which is impacted by temperature (paragraphs [0146]-[0147]); as well as by compression e.g. in press forming or shaping of the tablets (paragraphs [0109], [0136]). Arkenau-Maric also indicates that uniform density is desirable, and that dosage forms may be selected or rejected based on density (paragraphs [0139]-[0140]). In particular, it would have been obvious to select density values equal to or less than about 1.20 g/cm3 by optimization within the preferred density range suggested by Arkenau-Maric (from 0.95 to 1.25 g/cm3) for analogous oxycodone tablets.
Claim 170 is rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-30; 1-30; 1-29; 1-30; 1-30; 1-30; 1-30; 1-30; 1-30; 1-30; 1-30; 1-30; 1-30 of U.S. Patent Nos. 9486413 B2; 9492393 B2; 9492392 B2; 9492391 B2; 9492389 B2; 9545380 B2; 9763933 B2; 9763886 B2; 9770417 B2; 9770416 B2; 9775811 B2; 9775810 B2; 9775809 B2 respectively, each in view of CHAPMAN et al. (WO 2005097801 A1) and Arkenau-Maric et al. (US 20070048228 Al).
Each set of the issued claims of the designated patents teach solid/tablet composition, in the case of composition claims and in the case of the method claims, produce solid dosage forms that comprise polyethylene oxide (PEO) having molecular weights ranging from 4-7 million Da, 1-15 million Da, 1-8 million Da (US 9763933 B2 (4-7 million Da), US 9492389 B2 (4-7 million), US 9492393 B2 (4-7 million Da), US 9492392 B2 (4-7 million), US 9492391 B2 (4-7 million), US 9545380 B2 (4-7 million Da), US 9763933 B2 (4-7 million), US 9763886 B2 (1-15 million Da), US 9770417 B2 (1-8 million), US 9770416 B2 (1-8 million), US 9775811 B2 (1-8 million), US 9775810 B2 (1-15 million), US 9775809 B2 (1-15 million), the PEO is present from about 30% to 56%; the issued claims teach density of the shaped/tablet dosage forms without indicating that the density is determined by Archimedes Principle. However, determining the density of the shaped dosage forms by Archimedes Principle is the process of determining the density and the claims are not directed to method or process of determining density.
The issued claims differ from the examined claims by not teaching that the oxycodone hydrochloride salt contains low impurity level of less than about 25 ppm 14-hydroxycodeinone.
However, it is taught in the art that oxycodone hydrochloride contains 14-hydroxycodeinone because of how the oxycodone is made and that oxycodone hydrochloride composition having amounts of less than 25 ppm, less than 15 ppm, less than10 ppm and less than 5 ppm are preferred over oxycodone hydrochloride having greater than 100 ppm. Therefore, at before the effective date of the invention, the ordinary skilled artisan, guided by the teachings of CHAPMAN would use oxycodone hydrochloride having less than 25 ppm of the impurity, 14-hydroxycodeinone with the expectation of predictably having an extended release tablet dosage with having lower impurity level of 14-hydroxycodeinone.
The reference claims are silent with regards to the density of the shaped extended release tablet of the examined claims. However, the claimed density values appear to be an inherent to the ora1 dosage of the reference claims, Notwithstanding, it would also have been obvious to arrive at tablets having densities within the claimed range out of the course of routine optimization, when taken together with the additional teachings of Arkenau-Maric. Arkenau-Maric teaches dosage forms, including those containing oxycodone [0032], and indicate that preferable densities are in particular in the range from 0.95 to L25 g/cm 3 [0040]. Arkenau-Maric also indicates that density can be altered by experirnenta1 conditions including increasing volume, which is impacted by temperature (paragraphs [0146]-[0147]); as well as by compression e.g. in press forming or shaping of the tablets (paragraphs [0109], [0136]). Arkenau-Maric also indicates that uniform density is desirable, and that dosage forms may be selected or rejected based on density (paragraphs [0139]-[0140]). In particular, it would have been obvious to select density values equal to or less than about 1.20 g/cm3 by optimization within the preferred density range suggested by Arkenau-Maric (from 0.95 to 1.25 g/cm3) for analogous oxycodone tablets.
Therefore, the issued claims in view of CHAPMAN and Arkenau-Maric renders claim 170 prima facie obvious.
Claim 170 is rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 4, 27, 34, 35 and 37 of U.S. Patent No. 8894987 B2 in view of Arkenau-Maric et al. (US 20070048228 Al). Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims produce tablet dosage form comprising polyethylene oxide having molecular weight of 4,000,000, which is a point within the claimed range of 2-15 million Da, and which is present at least at 79% which is at least 30% (claims 1, 4); the formed tablet product having the oxycodone hydrochloride has 14-hydroxycodeinone at less than about 25 ppm (claim 27), and with the tablet shaped product having densities of 1.20 g/cm3 (claims 34, 35, 37). Determining the density by Archimedes Principle is the process of determining the density. Claim 170 is not directed to process of determining density of tablet.
The reference claims are silent with regards to the density of the shaped extended release tablet of the examined claims. However, the claimed density values appear to be an inherent to the ora1 dosage of the reference claims, Notwithstanding, it would also have been obvious to arrive at tablets having densities within the claimed range out of the course of routine optimization, when taken together with the additional teachings of Arkenau-Maric. Arkenau-Maric teaches dosage forms, including those containing oxycodone [0032], and indicate that preferable densities are in particular in the range from 0.95 to L25 g/cm 3 [0040]. Arkenau-Maric also indicates that density can be altered by experirnenta1 conditions including increasing volume, which is impacted by temperature (paragraphs [0146]-[0147]); as well as by compression e.g. in press forming or shaping of the tablets (paragraphs [0109], [0136]). Arkenau-Maric also indicates that uniform density is desirable, and that dosage forms may be selected or rejected based on density (paragraphs [0139]-[0140]). In particular, it would have been obvious to select density values equal to or less than about 1.20 g/cm3 by optimization within the preferred density range suggested by Arkenau-Maric (from 0.95 to 1.25 g/cm3) for analogous oxycodone tablets.
Claim 170 is rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-3; and 1-3 of U.S. Patent Nos. 11904055 B2 and 11938225 respectively, each in view of Arkenau-Maric et al. (US 20070048228 Al). Although the claims at issue are not identical, they are not patentably distinct from each other because the issued methods use tablet dosage form comprising polyethylene oxide (PEO) having molecular weight of 2-8 million Da, oxycodone hydrochloride having 14-hydroxycodeinone at a level of less than 25 ppm (claim 1) and the PEO is present at least about 30% (claim 1), at least about 65% (claim 2) and at least about 80% (claim 3).
The issued claims do not teach density of the solid tablet form. However, a product such as a tablet having a certain weight would occupy a certain volume, such that a tablet dosage form would have a certain density. There is however, no data showing that the claimed density provides the tablet dosage form unexpected results.
Determining the density by Archimedes Principle is the process of determining the density. Claim 170 is not directed to process of determining density of tablet.
The reference claims are silent with regards to the density of the shaped extended release tablet of the examined claims. However, the claimed density values appear to be an inherent to the ora1 dosage of the reference claims, Notwithstanding, it would also have been obvious to arrive at tablets having densities within the claimed range out of the course of routine optimization, when taken together with the additional teachings of Arkenau-Maric. Arkenau-Maric teaches dosage forms, including those containing oxycodone [0032], and indicate that preferable densities are in particular in the range from 0.95 to L25 g/cm 3 [0040]. Arkenau-Maric also indicates that density can be altered by experirnenta1 conditions including increasing volume, which is impacted by temperature (paragraphs [0146]-[0147]); as well as by compression e.g. in press forming or shaping of the tablets (paragraphs [0109], [0136]). Arkenau-Maric also indicates that uniform density is desirable, and that dosage forms may be selected or rejected based on density (paragraphs [0139]-[0140]). In particular, it would have been obvious to select density values equal to or less than about 1.20 g/cm3 by optimization within the preferred density range suggested by Arkenau-Maric (from 0.95 to 1.25 g/cm3) for analogous oxycodone tablets.
Therefore, issued claims 1-3; and 1-3 of U.S. Patent Nos. 11904055 B2 and 11938225 respectively in view of Arkenau-Maric render claim 170 prima facie obvious.
Claim 170 is rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-2, 15-23, 27, 29-30; 1-2, 6, 15-23, and 27-30; and 1-2, 6, 7, 8, 9, 13, 14, 15, 16, 18, 19, 20 and 30 of U.S. Patent Nos. 8894988 B2; 8911719 B2; and 10076499 B2 respectively, each in view of CHAPMAN et al. (WO 2005097801 A1) and Arkenau-Maric et al. (US 20070048228 Al).
US 8894988 B2: Teaches tablet dosage from comprising polyethylene oxide having molecular weight of 4 million and present at least at 54% or 79% or 57% (claims 1, 2, 15-23), oxycodone hydrochloride and the tablet has densities recited in claims 27, 29 and 30.
US 8894988 B2 does not teach the level of 14-hydroxycodeinone in the oxycodone hydrochloride composition.
US 8911719 B2: teaches shaped extended tablet dosage form comprising polyethylene oxide having molecular weight of approximately 4 million Da and is at least 79%, 72%, 54%, 57% (Claims 1-2, 6, 15, 16, 17, 18, 20, 21, 22, 23), oxycodone hydrochloride (claims 1, 15-23), and further teaches densities of the tablet dosage form (claims 27-30).
US 8911719 B2 does not teach the level of 14-hydroxycodeinone in the oxycodone hydrochloride composition.
US 10076499 B2: Teaches extended tablet dosage form comprising at least 54% or 79% or 72% or 57% or 54% polyethylene oxide having molecular weight of 4-7 million and oxycodone hydrochloride (claims 1-2, 6, 7, 8, 9, 13, 14, 15, 16, 20) and further teaches densities of the tablet dosage form (claims 18, 19, 30).
US 10076499 B2 does not teach the level of 14-hydroxycodeinone in the oxycodone hydrochloride composition.
However, it is taught in the art that oxycodone hydrochloride contains 14-hydroxycodeinone because of how the oxycodone is made and that oxycodone hydrochloride composition having amounts of less than 25 ppm, less than 15 ppm, less than10 ppm and less than 5 ppm are preferred over oxycodone hydrochloride having greater than 100 ppm. Therefore, at before the effective date of the invention, the ordinary skilled artisan, guided by the teachings of CHAPMAN would use oxycodone hydrochloride having less than 25 ppm of the impurity, 14-hydroxycodeinone with the expectation of predictably having an extended release tablet dosage with having lower impurity level of 14-hydroxycodeinone.
The reference claims are silent with regards to the density of the shaped extended release tablet of the examined claims. However, the claimed density values appear to be an inherent to the ora1 dosage of the reference claims, Notwithstanding, it would also have been obvious to arrive at tablets having densities within the claimed range out of the course of routine optimization, when taken together with the additional teachings of Arkenau-Maric. Arkenau-Maric teaches dosage forms, including those containing oxycodone [0032], and indicate that preferable densities are in particular in the range from 0.95 to L25 g/cm 3 [0040]. Arkenau-Maric also indicates that density can be altered by experirnenta1 conditions including increasing volume, which is impacted by temperature (paragraphs [0146]-[0147]); as well as by compression e.g. in press forming or shaping of the tablets (paragraphs [0109], [0136]). Arkenau-Maric also indicates that uniform density is desirable, and that dosage forms may be selected or rejected based on density (paragraphs [0139]-[0140]). In particular, it would have been obvious to select density values equal to or less than about 1.20 g/cm3 by optimization within the preferred density range suggested by Arkenau-Maric (from 0.95 to 1.25 g/cm3) for analogous oxycodone tablets.
Therefore, US 8894988 B2, US 8911719 B2 and US 10076499 B2, each in view of CHAPMAN and Arkenau-Maric renders claim 170 prima facie obvious.
Claim 170 is rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-2, 6, 8-10, 17 and 19-27; 1-2, 6, 9, 16 and 19-26; 1, 7, 8, 11-15, 17-19, 21-23 and 25-30; 1, 7-8, 13-15, 17-19, 21-23, 25, 27 and 28; 1, 5-7, 14-16, 19-23, 25-30; and 1, 5-7 and 11 of U.S. Patent Nos. 8808741 B2; 8821929 B2; 11304908 B2; 11304909 B2; 11298322 B2; and 11911510 B2 respectively, each in view of CHAPMAN et al. (WO 2005097801 A1) and Arkenau-Maric et al. (US 20070048228 Al).
In claim 170, convection heating and shaping the extended release matrix to form a tablet is the process of making the extended release tablet dosage form.
US 8808741 B2: Teaches treating pain with an extended release tablet dosage form comprising polyethylene oxide having molecular weight of about 4 million, which is a specific point within the claimed range of 2-15 million Da, the polyethylene oxide is present at least in amounts of 79%, 72%, 57%, or 54%, and oxycodone or oxycodone hydrochloride salt (claims 1-2, 6, 8-10, 17, 19-27). The comprising language is open. With regards to the density of the extended release dosage form, it is known that an object that has mass/weight and volume intrinsically has density as density is calculated as mass divided by volume. In the instant case, the instant specification has not provided factual evidence that the claimed density of 1.20 g/cm3 provides unexpected result to the extended release tablet dosage form.
US 8808741 B2 does not teach the level of 14-hydroxycodeinone in the oxycodone hydrochloride composition.
US 8821929 B2: teaches preparing extended release solid oral dosage form (tablet) comprising polyethylene glycol and oxycodone/oxycodone hydrochloride pharmaceutically acceptable salt; the polyethylene oxide has a molecular weight of about 4 million, which is a point within the claimed range of 2-15 million Da, and is present in at least 79%, 72%, 57^ or 54% (claims 1-2, 6, 9, 16 and 19-26). The comprising language is open. With regards to the density of the extended release dosage form, it is known that an object that has mass/weight and volume intrinsically has density as density is calculated as mass divided by volume. In the instant case, the instant specification has not provided factual evidence that the claimed density of 1.20 g/cm3 provides unexpected result to the extended release tablet dosage form.
US 8821929 B2 does not teach the level of 14-hydroxycodeinone in the oxycodone hydrochloride composition.
US 11304908 B2: teaches extended release solid oral dosage form (tablet) comprising oxycodone or pharmaceutically acceptable salt and polyethylene oxide present in at least about 20%, 30%, or 50% and the molecular weight of the polyethylene oxide is at least 800,000, 1,000,000 or 4,000,000 (claims 1, 7, 8, 11-15, 17-19, 21-23 and 25-30). Oxycodone hydrochloride is a known pharmaceutical salt of oxycodone. The comprising language is open. With regards to the density of the extended release dosage form, it is known that an object that has mass/weight and volume intrinsically has density as density is calculated as mass divided by volume. In the instant case, the instant specification has not provided factual evidence that the claimed density of 1.20 g/cm3 provides unexpected result to the extended release tablet dosage form.
US 11304908 B2 does not teach the level of 14-hydroxycodeinone in the oxycodone hydrochloride composition.
US 11304909 B2: teaches treating pain with extended release solid oral dosage form (tablet) comprising oxycodone or pharmaceutically acceptable salt and polyethylene oxide present in at least about 20%, 30%, or 50% and the molecular weight of the polyethylene oxide is at least 800,000, 1,000,000 or 4,000,000 (claims 1, 7-8, 13-15, 17-19, 21-23, 25, 27 and 28) with the 40,000,000 being a specific point within the claimed range of 2-15 million. Oxycodone hydrochloride is a known pharmaceutical salt of oxycodone. The comprising language is open. With regards to the density of the extended release dosage form, it is known that an object that has mass/weight and volume intrinsically has density as density is calculated as mass divided by volume. In the instant case, the instant specification has not provided factual evidence that the claimed density of 1.20 g/cm3 provides unexpected result to the extended release tablet dosage form.
US 11304909 B2 does not teach the level of 14-hydroxycodeinone in the oxycodone hydrochloride composition.
US 11298322 B2: teaches preparing solid (tablet) oral extended release dosage form comprising polyethylene oxide and oxycodone/oxycodone pharmaceutically acceptable salt; polyethylene oxide present in at least about 20%, 30%, or 50% and the molecular weight of the polyethylene oxide is at least 800,000, 1,000,000 or 4,000,000 (claims 1, 5-7, 14-16, 19-23, 25-30). Oxycodone hydrochloride is a known pharmaceutical salt of oxycodone. The comprising language is open. With regards to the density of the extended release dosage form, it is known that an object that has mass/weight and volume intrinsically has density as density is calculated as mass divided by volume. In the instant case, the instant specification has not provided factual evidence that the claimed density of 1.20 g/cm3 provides unexpected result to the extended release tablet dosage form.
US 11298322 B2 does not teach the level of 14-hydroxycodeinone in the oxycodone hydrochloride composition.
US 11911510 B2: teaches solid oral extended release dosage form comprising oxycodone hydrochloride and polyethylene oxide; the polyethylene oxide is present in at least about 40%, 50-90% and the molecular weight of the polyethylene oxide is about 900,000 to 8,000,000 or 4,000,000 to 8,000,000 (claims 1, 5-7 and 11). Tablets are known solid oral dosage form. The comprising language is open. With regards to the density of the extended release dosage form, it is known that an object that has mass/weight and volume intrinsically has density as density is calculated as mass divided by volume. In the instant case, the instant specification has not provided factual evidence that the claimed density of 1.20 g/cm3 provides unexpected result to the extended release tablet dosage form.
US 11911510 B2 does not teach the level of 14-hydroxycodeinone in the oxycodone hydrochloride composition.
However, it is taught in the art that oxycodone hydrochloride contains 14-hydroxycodeinone because of how the oxycodone is made and that oxycodone hydrochloride composition having amounts of less than 25 ppm, less than 15 ppm, less than10 ppm and less than 5 ppm are preferred over oxycodone hydrochloride having greater than 100 ppm. Therefore, at before the effective date of the invention, the ordinary skilled artisan, guided by the teachings of CHAPMAN would use oxycodone hydrochloride having less than 25 ppm of the impurity, 14-hydroxycodeinone with the expectation of predictably having an extended release tablet dosage with having lower impurity level of 14-hydroxycodeinone.
The reference claims are silent with regards to the density of the shaped extended release tablet of the examined claims. However, the claimed density values appear to be an inherent to the ora1 dosage of the reference claims, Notwithstanding, it would also have been obvious to arrive at tablets having densities within the claimed range out of the course of routine optimization, when taken together with the additional teachings of Arkenau-Maric. Arkenau-Maric teaches dosage forms, including those containing oxycodone [0032], and indicate that preferable densities are in particular in the range from 0.95 to L25 g/cm 3 [0040]. Arkenau-Maric also indicates that density can be altered by experirnenta1 conditions including increasing volume, which is impacted by temperature (paragraphs [0146]-[0147]); as well as by compression e.g. in press forming or shaping of the tablets (paragraphs [0109], [0136]). Arkenau-Maric also indicates that uniform density is desirable, and that dosage forms may be selected or rejected based on density (paragraphs [0139]-[0140]). In particular, it would have been obvious to select density values equal to or less than about 1.20 g/cm3 by optimization within the preferred density range suggested by Arkenau-Maric (from 0.95 to 1.25 g/cm3) for analogous oxycodone tablets.
Therefore, US 8808741 B2, US 8821929 B2, US 11304908 B2, US 11304909 B2, US 11298322 B2 and 11911510 B2, each in view of CHAPMAN and Arkenau-Maric renders claim 170 prima facie obvious.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
Prosecution Insights