DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 24-43 are pending and under consideration.
Information Disclosure Statement
The Information Disclosure Statement filed on 12/22/2023 has been considered.
Priority
The instant application is a CON of US 13/538,812 filed on 6/29/2012, which is a CON of US 15/009,601 filed on 1/28/2016, which is a CON of US Appl. No. 15/716,259 filed on 9/26/2017, which is a CON of US 16/391,087 filed on 4/22/2019, which is a CON of US 17/170,479 filed on 2/8/2021.
Claim Objections
Claim 33 is objected to because of the following informalities:
Claim 33 is objected for the use of an abbreviated phrase (PGLA), which should be described for the first time followed by an abbreviated form placed in a bracket.
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 24-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 9,259,386. Although the claims at issue are not identical, they are not patentably distinct from each other because a therapeutic preparation comprising somatostatin or somatostatin analogue, the preparation being formed as, or disposed in, a solid tissue penetrating member shaped and configured to penetrate a gastro-intestinal (GI) wall of a patient after oral ingestion by an application of a force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon penetrating the GI wall, the solid tissue penetrating member degrades to release somatostatin or somatostatin analogue in the patient, wherein the entire preparation is in solid form, wherein the preparation is adapted to be orally delivered in a swallowable capsule, wherein the expandable member has a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the GI wall in the second configuration, wherein the expandable member comprises an expandable balloon having an expanded and a non-expanded state, and wherein the first configuration is the non-expanded state and the second configuration is the expanded state, wherein the expandable member comprises a spring, wherein the GI wall is a wall of the stomach, wherein the GI wall is a wall of the intestine, wherein the preparation comprises a biodegradable material which degrades to release somatostatin or somatostatin analogue, wherein the biodegradable material comprises at least one of PGLA or a sugar, wherein the preparation comprises at least one pharmaceutical excipient, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative, or a disintegrant, wherein the solid tissue penetrating member comprises a biodegradable material which degrades to release somatostatin or somatostatin analogue, wherein a weight percent of somatostatin or somatostatin analogue in the tissue penetrating member comprises between about 0.3 to 8%, wherein the tissue penetrating member includes a retaining feature for retaining the tissue penetrating member in the GI wall, wherein the somatostatin or somatostatin analogue is contained in the tissue penetrating member in a shaped section, wherein the shaped section has a cylinder or pellet shape, wherein a Cmax achieved by delivering the preparation by insertion into an intestinal wall is substantially greater than a Cmax achieved when the preparation is delivered orally without insertion into the intestinal wall, wherein the somatostatin analogue is octreotide, and wherein a dose of somatostatin or somatostatin analogue in the preparation is in a range of about 50 to 600 mg are taught in claims 1-29 of U.S. Patent No. 9,259,386.
Claims 24-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18,20-23 and 26-27 of U.S. Patent No. 9,814,763. Although the claims at issue are not identical, they are not patentably distinct from each other because a therapeutic preparation comprising somatostatin or somatostatin analogue, the preparation being formed as, or disposed in, a solid tissue penetrating member shaped and configured to penetrate a gastro-intestinal (GI) wall of a patient after oral ingestion by an application of a force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon penetrating the GI wall, the solid tissue penetrating member degrades to release somatostatin or somatostatin analogue in the patient, wherein the entire preparation is in solid form, wherein the preparation is adapted to be orally delivered in a swallowable capsule, wherein the expandable member has a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the GI wall in the second configuration, wherein the expandable member comprises an expandable balloon having an expanded and a non-expanded state, and wherein the first configuration is the non-expanded state and the second configuration is the expanded state, wherein the expandable member comprises a spring, wherein the GI wall is a wall of the stomach, wherein the GI wall is a wall of the intestine, wherein the preparation comprises a biodegradable material which degrades to release somatostatin or somatostatin analogue, wherein the biodegradable material comprises at least one of PGLA or a sugar, wherein the preparation comprises at least one pharmaceutical excipient, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative, or a disintegrant, wherein the solid tissue penetrating member comprises a biodegradable material which degrades to release somatostatin or somatostatin analogue, wherein a weight percent of somatostatin or somatostatin analogue in the tissue penetrating member comprises between about 0.3 to 8%, wherein the tissue penetrating member includes a retaining feature for retaining the tissue penetrating member in the GI wall, wherein the somatostatin or somatostatin analogue is contained in the tissue penetrating member in a shaped section, wherein the shaped section has a cylinder or pellet shape, wherein a Cmax achieved by delivering the preparation by insertion into an intestinal wall is substantially greater than a Cmax achieved when the preparation is delivered orally without insertion into the intestinal wall, wherein the somatostatin analogue is octreotide, and wherein a dose of somatostatin or somatostatin analogue in the preparation is in a range of about 50 to 600 mg are taught in claims 1-18,20-23 and 26-27 of U.S. Patent No. 9,814,763.
Claims 24-32, 34-39 and 41-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7, 10-18 of U.S. Patent No. 10,314,892. Although the claims at issue are not identical, they are not patentably distinct from each other because a therapeutic preparation comprising somatostatin or somatostatin analogue, the preparation being formed as, or disposed in, a solid tissue penetrating member shaped and configured to penetrate a gastro-intestinal (GI) wall of a patient after oral ingestion by an application of a force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon penetrating the GI wall, the solid tissue penetrating member degrades to release somatostatin or somatostatin analogue in the patient, wherein the entire preparation is in solid form, wherein the preparation is adapted to be orally delivered in a swallowable capsule, wherein the expandable member has a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the GI wall in the second configuration, wherein the expandable member comprises an expandable balloon having an expanded and a non-expanded state, and wherein the first configuration is the non-expanded state and the second configuration is the expanded state, wherein the expandable member comprises a spring, wherein the GI wall is a wall of the stomach, wherein the GI wall is a wall of the intestine, wherein the preparation comprises a biodegradable material which degrades to release somatostatin or somatostatin analogue, wherein the preparation comprises at least one pharmaceutical excipient, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative, or a disintegrant, wherein the solid tissue penetrating member comprises a biodegradable material which degrades to release somatostatin or somatostatin analogue, wherein a weight percent of somatostatin or somatostatin analogue in the tissue penetrating member comprises between about 0.3 to 8% are taught in claims 1, 4-7, 10-18 of U.S. Patent No. 10,314,892.
Claims 24-32, 34-39 and 42-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-8, 11-18 of U.S. Patent No. 10,953,077. Although the claims at issue are not identical, they are not patentably distinct from each other because a therapeutic preparation comprising somatostatin or somatostatin analogue, the preparation being formed as, or disposed in, a solid tissue penetrating member shaped and configured to penetrate a gastro-intestinal (GI) wall of a patient after oral ingestion by an application of a force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon penetrating the GI wall, the solid tissue penetrating member degrades to release somatostatin or somatostatin analogue in the patient, wherein the entire preparation is in solid form, wherein the preparation is adapted to be orally delivered in a swallowable capsule, wherein the expandable member has a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the GI wall in the second configuration, wherein the expandable member comprises an expandable balloon having an expanded and a non-expanded state, and wherein the first configuration is the non-expanded state and the second configuration is the expanded state, wherein the expandable member comprises a spring, wherein the GI wall is a wall of the stomach, wherein the GI wall is a wall of the intestine, wherein the preparation comprises a biodegradable material which degrades to release somatostatin or somatostatin analogue, wherein the preparation comprises at least one pharmaceutical excipient, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative, or a disintegrant, wherein the solid tissue penetrating member comprises a biodegradable material which degrades to release somatostatin or somatostatin analogue, wherein a weight percent of somatostatin or somatostatin analogue in the tissue penetrating member comprises between about 0.3 to 8% are taught in claims 1-2, 5-8, 11-18 of U.S. Patent No. 10,953,077.
Claims 24-32, 34-39 and 42-43 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,813,314. Although the claims at issue are not identical, they are not patentably distinct from each other because a therapeutic preparation comprising somatostatin or somatostatin analogue, the preparation being formed as, or disposed in, a solid tissue penetrating member shaped and configured to penetrate a gastro-intestinal (GI) wall of a patient after oral ingestion by an application of a force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon penetrating the GI wall, the solid tissue penetrating member degrades to release somatostatin or somatostatin analogue in the patient, wherein the entire preparation is in solid form, wherein the preparation is adapted to be orally delivered in a swallowable capsule, wherein the expandable member has a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the GI wall in the second configuration, wherein the expandable member comprises an expandable balloon having an expanded and a non-expanded state, and wherein the first configuration is the non-expanded state and the second configuration is the expanded state, wherein the expandable member comprises a spring, wherein the GI wall is a wall of the stomach, wherein the GI wall is a wall of the intestine, wherein the preparation comprises a biodegradable material which degrades to release somatostatin or somatostatin analogue, wherein the preparation comprises at least one pharmaceutical excipient, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative, or a disintegrant, wherein the solid tissue penetrating member comprises a biodegradable material which degrades to release somatostatin or somatostatin analogue, wherein a weight percent of somatostatin or somatostatin analogue in the tissue penetrating member comprises between about 0.3 to 8% are taught in claims 1-11 of U.S. Patent No. 11,813,314.
Conclusion
No claim is allowed.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674