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 .
Status of Application
Receipt of the Preliminary Amendment filed on August 23, 2024 is acknowledged.
Claims 2-13 are pending in this application.
Claim 1 has been cancelled.
Claims 2-13 are new.
All pending claims are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on August 26, 2024 is acknowledged. A signed copy is attached to this office action.
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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Claim 2-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11, 752,217. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patented independent claims are both drawn to hydrogel prodrug delivery system comprising:
a copolymer comprising:
a prodrug which generates a drug upon hydrolysis, a primary linker molecule and a secondary linker molecule;
wherein the prodrug is covalently bound within the copolymer during polymerization of the copolymer by one or more of the following chemical linkages: ester, thioester, amide, or acid anhydride;
wherein the primary linker molecule is terminated on each end by at least two functional groups, which are reactive and configured to form said one or more chemical linkages with at least two functional groups on said prodrug;
wherein the molar equivalents of said primary linker molecule exceed the molar equivalents of said prodrug;
wherein said secondary linker molecule comprises two functional groups configured to form covalent bonds with functional groups on the primary linker molecule;
wherein the copolymer is formulated to release the drug upon degradation of the copolymer via hydrolysis.
The instant claims additionally recite:
wherein the primary linker molecule is formed by reacting: at least one molecule that comprises at least one amine group, at least one diacrylate, and at least one molecule that is terminated at one end with a carboxylic acid; and
wherein the molar ratio of the at least one diacrylate to the drug is between about 1.05:1 and about 5:1.
However, these limitations are recited in dependent claims in the patent.
Claim 2-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,331,395. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patented independent claims are both drawn to hydrogel prodrug delivery system comprising:
a copolymer, comprising:
a prodrug which generates a drug upon hydrolysis, a primary linker molecule and a secondary linker molecule;
wherein the prodrug is covalently bound within the copolymer during polymerization of the copolymer by one or more of the following chemical linkages: ester, thioester, amide, or acid anhydride;
wherein the primary linker molecule is terminated on each end by at least two functional groups, which are reactive and configured to form said one or more chemical linkages with at least two functional groups on said prodrug;
wherein the molar equivalents of said primary linker molecule exceed the molar equivalents of said prodrug;
wherein said secondary linker molecule comprises two functional groups configured to form covalent bonds with functional groups on the primary linker molecule thereby cross-linking to the prodrug molecule;
wherein the copolymer is formulated to release the drug upon degradation of the copolymer via hydrolysis;
The instant claims additionally recite:
wherein the primary linker molecule is formed by reacting: at least one molecule that comprises at least one amine group, at least one diacrylate, and at least one molecule that is terminated at one end with a carboxylic acid; and
wherein the molar ratio of the at least one diacrylate to the drug is between about 1.05:1 and about 5:1.
However, these limitations are recited in dependent claims in the patent.
Claim 2-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,406,241. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patented independent claims are both drawn to hydrogel prodrug delivery system comprising:
a copolymer, comprising:
a prodrug which generates a drug upon hydrolysis, a primary linker molecule and a secondary linker molecule;
wherein the prodrug is covalently bound within the copolymer during polymerization of the copolymer by one or more of the following chemical linkages: ester, thioester, amide, or acid anhydride;
wherein the primary linker molecule is terminated on each end by at least two functional groups, which are reactive and configured to form said one or more chemical linkages with at least two functional groups on said prodrug;
wherein the molar equivalents of said primary linker molecule exceed the molar equivalents of said prodrug;
wherein said secondary linker molecule comprises two functional groups configured to form covalent bonds with functional groups on the primary linker molecule thereby cross-linking to the prodrug molecule;
wherein the copolymer is formulated to release the drug upon degradation of the copolymer via hydrolysis;
The instant claims additionally recite:
wherein the primary linker molecule is formed by reacting: at least one molecule that comprises at least one amine group, at least one diacrylate, and at least one molecule that is terminated at one end with a carboxylic acid; and
wherein the molar ratio of the at least one diacrylate to the drug is between about 1.05:1 and about 5:1.
However, these limitations are recited in dependent claims in the patent.
Examiners Note
The closest prior art of Hersel (US 2006/0002890), which is cited in the parent application 15/630645, does not disclose the prodrug is integrated into the polymer via the polymerization process and formation of the hydrogel. Hersel discloses the prodrug is added to the polymer after the after the hydrogel is formed. This results in a structurally different hydrogel formulation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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