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 15-44 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 .
Drawings
The drawings were received on 09/11/2025. These drawings are acknowledged.
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 15-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 10,398,791. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to the same art specific subject matter.
The present invention is directed to composition comprising compounds of formula (Ia’) or metal complex, pharmaceutically acceptable salts or solvates thereof:
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198
564
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Wherein:
RX comprises a chelator;
n is 1; m is 1, 2, 3, or 4;
X is naphthyl, phenyl, biphenyl, indolyl (=2,3-benzopyrrolyl), or benzothiazolyl; each Y is independently aryl, alkylaryl, cyclopentyl, cyclohexyl, or cycloheptyl; and each Z is independently -CO2H, -SO₂H, -SO₃H, -SO4H, -PO₂H, -PO₃H, or -PO4H₂. Chelator is chosen from: DOTA; HBED-CC; NOTA; … radionuclide is chosen from ⁸⁹Zr, 44Sc,¹¹¹In, 90Y, ⁶Ga, ⁶⁷Ga, ⁶⁸Ga, ¹⁷⁷Lu, ⁹⁹ᵐTc, ⁶⁴Cu, ⁶⁷Cu, ¹⁴⁹Tb, ¹⁵²Tb, ¹⁵⁵Tb, ¹⁶¹Tb, 1⁵³Gd, ¹⁵⁵Gd, ¹⁵⁷Gd, 2¹³Bi, 225Ac, 2³⁰U, ²²³Ra, ¹⁶⁵Er, ¹²³, ¹³¹, or Fe.
The claims 1-30 of U.S. Patent No. 10,398,791; claims 1-15 of US 11,045,564; and claims 1-15 of US 11,931,430 are directed to composition comprising compounds, metal complex (reads on compound of formula Ia’) and pharmaceutically acceptable carrier:
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461
476
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.
The difference between the instant claims and issued patent claims is in scope only. The compounds of US 10,398,791; claims 1-15 of US 11,045,564; and claims 1-15 of US 11,931,430 fall under the scope of the instantly claimed compounds are overlapping and the differences are considered to be obvious over each other. Thus, the instantly claimed subject matter are not patently distinct over the issued patents.
Claims 15-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. claims 1-28 of U.S. Patent No. 10,471,160 and claims 1-60 of US 11,951,190. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to the same art specific subject matter.
The present invention is directed to composition comprising compounds of formula (Ia’) or metal complex, pharmaceutically acceptable salts or solvates thereof:
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198
564
media_image1.png
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Wherein:
RX comprises a chelator;
n is 1; m is 1, 2, 3, or 4;
X is naphthyl, phenyl, biphenyl, indolyl (=2,3-benzopyrrolyl), or benzothiazolyl; each Y is independently aryl, alkylaryl, cyclopentyl, cyclohexyl, or cycloheptyl; and each Z is independently -CO2H, -SO₂H, -SO₃H, -SO4H, -PO₂H, -PO₃H, or -PO4H₂. Chelator is chosen from: DOTA; HBED-CC; NOTA; … radionuclide is chosen from ⁸⁹Zr, 44Sc,¹¹¹In, 90Y, ⁶Ga, ⁶⁷Ga, ⁶⁸Ga, ¹⁷⁷Lu, ⁹⁹ᵐTc, ⁶⁴Cu, ⁶⁷Cu, ¹⁴⁹Tb, ¹⁵²Tb, ¹⁵⁵Tb, ¹⁶¹Tb, 1⁵³Gd, ¹⁵⁵Gd, ¹⁵⁷Gd, 2¹³Bi, 225Ac, 2³⁰U, ²²³Ra, ¹⁶⁵Er, ¹²³, ¹³¹, or Fe.
The claims 1-28 of U.S. Patent No. 10,471,160 and claims 1-60 of US 11,951,190 are directed to composition comprising compounds, metal complex and pharmaceutically acceptable carrier:
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383
434
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wherein: n is chosen from 0 or 1; m is chosen from 1, 2, 3, or 4; X is chosen from naphthyl, phenyl, biphenyl, Indolyl (=2,3-benzopyrrolyl), or benzothiazolyl; Y is chosen from aryl, alkylaryl, cyclopentyl, cyclohexyl, or cycloheptyl; and Z is independently chosen from —CO2H, —SO2H, —SO3H, —SO4H, —PO2H, —PO3H, or —PO4H2 their use in diagnosing and treating prostate cancer and/or metastasis thereof.
The difference between the instant claims and issued patent claims is in scope only. The compounds of US 10,471,160 and US 11,951,190 fall under the scope of the instantly claimed compounds are overlapping and the differences are considered to be obvious over each other .Thus, the instantly claimed subject matter are not patently distinct over the issued patents.
“Structural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions, create a prima facie case of obviousness." Takeda V. Alphapharm, 83 USPQ2d 1169 (Fed. Cir. 2007) (quoting In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990). "The 'reason or motivation' need not be an explicit teaching that the claimed compound will have a particular utility; it is sufficient to show that the claimed and prior art compounds possess a 'sufficiently close relationship to create an expectation,' in light of the totality of the prior art, that the new compound will have 'similar properties' to the old." Aventis V. Lupin, 84 USPQ2d 1197 (Fed. Cir. 2007) (citing Dillion, 919 F.2d 692). "Once such prima facie case is established, it falls to the applicant or patentee to rebut it, for example with a showing that the claimed compound has unexpected properties." Id. MPEP 804 states : "where the claims of an application are not the "same" as those of the first patent, but the grant of a patent with the claims in the application would unjustly extend the rights granted by the first patent, a double patenting rejection under nonstatutory grounds is proper."
Although the conflicting claims are not identical, the Examiner finds that a person having ordinary skill in the art would recognize that the claimed invention would unjustly extend the rights granted to U.S. Patent No. 10,398,791, 10,471,160, 11,045,564, 11,931,430 and 11,951,190 because a hypothetical infringer of U.S. Patent No. 10,398,791, 10,471,160, 11,045,564, 11,931,430 and 11,951,190 would necessarily be an infringer of the claimed invention. Accordingly, U.S. Patent No. 10,398,791, 10,471,160, 11,045,564, 11,931,430 and 11,951,190 renders the instant claims obvious absent a showing of unpredictability or comparative evidence suggesting otherwise.
Conclusion
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGADISHWAR RAO SAMALA whose telephone number is (571)272-9927. The examiner can normally be reached Monday-Friday 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Hartley G Michael can be reached at 571 272 0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.R.S/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618