DETAILED ACTION
Notice of Pre-AIA or AIA Status
This Office action details a first action on the merits for the above referenced application No. Claims 1, 25, 26, 30-33, 35-37, 44, 46, 47, 50, 54, 61, 64, 72, 75, 87, 88, 107, 113, 138 and 140-142 are pending in this application. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/15/2024 was noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 04/29/2024. These drawings are adknowledged.
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.
Claims 1, 25, 30, 31, 37, 44, 46, 47, 50, 54, 61, 64, 72, 87, 88 and 140-142 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,541,134. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claim is either anticipated, 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). Although the conflicting claims are not identical, they are not patentably distinct from each other because both the issued claims and the examined claims teach radiopharmaceutical compositions comprising 225Ac-DOTA-TATE or a pharmaceutically acceptable salt thereof, wherein the 225Ac-DOTA-TATE or the pharmaceutically acceptable salt thereof is present in the radiopharmaceutical composition at a concentration equivalent to 10 mCi/L to 50 mCi/L; (b) a pH stabilizer (c) a free metal chelator; and (d) an aqueous vehicle, wherein the aqueous vehicle is a saline solution; wherein the radiopharmaceutical composition is a solution, and wherein the radiopharmaceutical composition retains at least 85%-90% of the 225 Ac content as 225 Ac-DOTA-TATE or the pharmaceutically acceptable salt thereof after 48 hours-120 hours.
Claims 1, 107, and 138 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, 20 and 21 of U.S. Patent No. 11,497,822. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims are either anticipated, 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). Although the conflicting claims are not
identical, they are not patentably distinct from each other because both the issued claims and the examined claims teach a method of treating a somatostatin receptor-positive (SSTR+) neuroendocrine tumor in a subject in need thereof, comprising administering to the subject an effective amount of a liquid radiopharmaceutical composition, wherein the liquid radiopharmaceutical composition comprises: (a) 225Ac-DOTA-TATE or a pharmaceutically acceptable salt thereof, wherein the 225Ac-DOTA-TATE or the pharmaceutically acceptable salt thereof is present in the radiopharmaceutical
composition at a concentration equivalent to about 10 mCi/L to about 50 mCi/L; (b) p pH stabilizer; (c) a metal chelator and (d) an aqueous vehicle, wherein the aqueous vehicle is sodium chloride saline solution at a concentration of about 0.9% w/w; wherein the radiopharmaceutical composition is a solution, and wherein the radiopharmaceutical composition is administered to the subject in an amount equivalent to about 60 kBq/kg body weight to about 120 kBq/kg body weight per dose.
Claims 1, 25, 30, 31, 37, 44, 46, 47, 50, 54, 61, 64, 72, 87, 88 and 140-142 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,707,540. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims are either anticipated, 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). Although the conflicting claims are not identical, they are not patentably distinct from each other because both the issued claims and the examined claims teach radiopharmaceutical compositions comprising 225Ac-DOTA-TATE or a pharmaceutically acceptable salt thereof, wherein the .sup.225Ac-DOTA-TATE or the pharmaceutically acceptable salt thereof is present in the radiopharmaceutical composition at a concentration equivalent to 10 mCi/L to 50 mCi/L; (b) a pH stabilizer (c) a free metal chelator; and (d) an aqueous vehicle, wherein the aqueous vehicle is a saline
Solution.
Claims 1, 25, 30, 31, 37, 44, 46, 47, 50, 54, 61, 64, 72, 87, 88 and 140-142 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11, 819,556. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claim is either anticipated, 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). Although the conflicting claims are not identical, they are not patentably distinct from each other because both the issued claims and the examined claims teach radiopharmaceutical compositions comprising 225Ac-DOTA-TATE or a pharmaceutically acceptable salt thereof, wherein the 225Ac-DOTA-TATE or the pharmaceutically acceptable salt thereof is present in the radiopharmaceutical composition at a concentration equivalent to 10 mCi/L to 50 mCi/L; (b) a pH stabilizer (c) a free metal chelator; and (d) an aqueous vehicle, wherein the aqueous vehicle is a saline solution; wherein the radiopharmaceutical composition is a solution, and wherein the radiopharmaceutical composition retains at least 85%-90% of the 225 Ac content as 225 Ac-DOTA-TATE or the pharmaceutically acceptable salt thereof after 48 hours-120 hours.
Claims 1, 25, 30, 31, 37, 44, 46, 47, 50, 54, 61, 64, 72, 87, 88 and 140-142 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-15, 20 and 21 of copending Application No. 18/511,854 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the issued claims and the examined claims teach radiopharmaceutical compositions comprising 225Ac-DOTA-TATE or a pharmaceutically acceptable salt thereof, wherein the 225Ac-DOTA-TATE or the pharmaceutically acceptable salt thereof is present in the radiopharmaceutical composition at a concentration equivalent to 10 mCi/L to 50 mCi/L; (b) a pH stabilizer (c) a free metal chelator; and (d) an aqueous vehicle, wherein the aqueous vehicle is a saline solution; wherein the radiopharmaceutical composition is a solution, and wherein the radiopharmaceutical composition retains at least 85%-90% of the 225 Ac content as 225 Ac-DOTA-TATE or the pharmaceutically acceptable salt thereof after 48 hours-120 hours.
Claims 1, 25, 26, 30-33, 35-37, 44, 46, 47, 50, 54, 61, 64, 72, 75, 87, 88, 107, 113, 138 and 140-142 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 11,497, 822; 11,541,134; 11,707,540 and 11,819,556 in view of Chen et al. (US 2007/0269375). Although the claims at issue are not identical, they are not patentably distinct from each other because both the issued claims and the examined claims teach radiopharmaceutical compositions comprising 225Ac-DOTA-TATE or a pharmaceutically acceptable salt thereof, and a method of treating a somatostatin receptor-positive (SSTR+) neuroendocrine tumor in a subject in need thereof, comprising administering to the subject an effective amount of a liquid radiopharmaceutical composition, wherein the 225Ac-DOTA-TATE or the pharmaceutically acceptable salt thereof is present in the radiopharmaceutical composition at a concentration equivalent to 10 mCi/L to 50 mCi/L; (b) a pH stabilizer (c) a free metal chelator; and (d) an aqueous vehicle, wherein the aqueous vehicle is a saline solution; wherein the radiopharmaceutical composition is a solution, and wherein the radiopharmaceutical composition retains at least 85%-90% of the 225 Ac content as 225 Ac-DOTA-TATE or the pharmaceutically acceptable salt thereof after 48 hours-120 hours. The only difference between the instant claims and the patents recited claims Is the radiolysis stabilizers.
Chen discloses stabilized radiopharmaceutical formulations and methods of making and using stabilized radiopharmaceutical formulations. Stabilizers useful in the preparation and stabilization of radiopharmaceutical formulation includes tryptophan, tyrosine, histidine, cysteine, threonine, glutamic acid and aspartic acid (0026), water soluble organic selenium compounds and selenium compounds in combination with sodium ascorbate or other pharmaceutically acceptable forms of ascorbic acid and its derivatives.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate radiostabilizers into patents. The person of ordinary skill in the art would have motivated to make those modifications, because Chen teaches that stabilizers and stabilizer combinations slow or prevent radiolytic damage to targeted radiotherapeutic and radiodiagnostic radiolabeled compounds and reasonably would have expected success because it could improve the radiostability of radiotherapeutic and radiodiagnostic compounds and formulations containing them.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
It is respectfully requested of applicant to file all appropriate terminal disclaimers including any that applicant is aware and have not been listed in this office action.
Conclusion
No claims are allowed at this time.
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/J.R.S/ Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618