6183DETAILED 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 .
Receipt is acknowledged of Applicant’s Arguments filed on 05/25/2026.
Claims 15-29 are pending and presented for examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/26/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/02/2026 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.
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 15-29 are rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 1-30 of U.S. Patent No. 10,398,791, over claims 1-28 of U.S. Patent No. 10,471,160. Over claims 1-15 of U.S. Patent No. 11,045,564, and over claims 1-15 of U.S. Patent No. 11,931,430 in view of Albert et al. (US 6,183,721) are maintained for reasons of record in the previous office action filed on 11/26/2025.
Although the conflicting claims are not identical, they are not patentably distinct
from each other because the patents recite a compound of the formula:
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or salt thereof. The compound or salt thereof is lyophilized and comprises a
pharmaceutically acceptable carrier. The only difference between the instant claims and
the patents recited claims is the chelator (DOTA) is complexed with 161 Tb radioisotope.
Albert teaches chelated peptides, complexes thereof, pharmaceutical
compositions comprising a compound of formula or a compound of formula complexed
with a radionuclide and their use as radiopharmaceuticals
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Albert discloses that the complexation with the radionuclide may be performed at room temperature in accordance with methods known in the art, e.g., by reacting an uncomplexed compound with a salt yielding the desired radionuclide (Col. 2 line 63+). The radionuclide includes a- or ß- emitting nuclide e.g., 90Y, ¹⁴⁰La, ¹⁶¹Tb, ¹⁶⁹Er, 153Sm, ¹⁷⁷Lu, ¹⁶⁶Dy, ¹⁶⁶Ho or ¹⁷⁵Yb (Col. line 22-25).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate α- or ß- emitting nuclide e.g., 90Y, ¹⁴⁰La, ¹⁶¹Tb, ¹⁶⁹Er, ¹⁵³Sm, ¹⁷⁷Lu, ¹⁶⁶Dy, ¹⁶⁶Ho or 175Yb into patents as taught by Albert. The person of ordinary skill in the art would have been motivated to make those modifications, because Albert teaches that compound of formula I, when complexed with a radionuclide, exhibit pharmaceutical activity and are therefore useful as a radiopharmaceutical for the in vivo treatment of tumors and metastases as indicated by standard tests (Col 3 line 15-20) and reasonably would have expected success because the compounds complexed with radionuclide have an antiproliferative effect on tumor cells bearing somatostatin receptors.
NOTE: It possible to label DOTA peptide conjugates with radiometal ions such as 90Y, ¹⁴⁰La, ¹⁶¹Tb, ¹⁶⁹Er, Sm, ¹⁷⁷Lu, ¹⁶⁶Dy, ¹⁶⁶Ho or ¹⁷⁵Yb to high specific activity by optimizing the conditions such as pH, temperature, ligand to metal ratio and choice of buffer. Thus, "Tb chelate as claimed are considered to be obvious variants of cited chelates because Albert teaches that complexation with a radionuclide, exhibit pharmaceutical activity and because Tb forms thermodynamically and kinetically stable associates with macrocyclic chelator. Accordingly, claims are over lapping in scope and are obvious variants of one another.
"Factors that may be considered in determining level of ordinary skill in the art include: (1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) the education level of active workers in the field." Envtl. Designs, Ltd. V. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. V. All Orthopedic Appliances, Inc., 707 F.3d 1376, 1381-82 (Fed. Cir. 1983)). The above factors are not exhaustive, but are a guide. Id.
In this case, the education level of the inventor and the education level of active workers in the field of organic chemistry, as well as the high degree of sophistication required to solve problems encountered in the art, a person of ordinary skill in the art would likely have at least a college degree in the field of organic chemistry, with industry experience, i.e., a masters or doctorate level of skill and knowledge in the laboratory. Thus, the level of skill in the art is relatively high.
"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 /n 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. Patents, because a hypothetical infringer of U.S. Patent granted would necessarily be an infringer of the claimed invention.
Accordingly, U.S. Patent No. 10,398,791, 10,471,160, 11,045,564, and 1,931,430 renders the instant claims obvious absent a showing of unpredictability or comparative evidence suggesting otherwise.
Applicant arguments filed on 05/26/2026 have been fully considered but they are not persuasive. Applicant argues that the claims are within the safe harbor provision of 35 U.S.C. § 121 ("[a] patent issuing on an application with respect to which a requirement for restriction under this section has been made shall not be used" as an obviousness-type double patenting reference against "an application filed as a result of such a requirement"). This argument is not persuasive. In response to the Election of Species requirement (Parent Appl. 16/114,988 mailed on 01/10/2019), Applicants has amended and canceled claims (17-31) herein to cancel subject matter directed to non-elected radionuclides without traverse. The election of species requirement was mailed to streamline examination for searching specific radionuclide and extend search of the non-elected species. If the elected species were found free of prior art, the non-elected species would be rejoined at the time of allowance. However, since all the non-elected species were canceled, a person of ordinary skill in the art would recognize that the claimed invention would unjustly extend the rights granted to US patent No. (10,398,791, 10,471,160, 11,045,564, and 1,931,430) and therefore the instant claims would be obvious absent a showing of unpredictability.
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
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