Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 3/31/2026 wherein claims 1-19 were canceled and claims 20-29 were added. In addition, the Examiner acknowledges the substitute specification filed 3/31/2026.
Note(s): Claims 1-19 are pending.
Priority
This application is a CON of 17383577 filed 7/23/2021 (now US Patent No. 12,064,491); 17/383,577 is a CON of 16/580,990 filed 9/24/2019 (now US Patent No. 11,083,805);
16/580,990 is a CON of 15/817,776 filed 11/20/2017;
15/817,776 is a CON of 14/431,096 filed 3/25/2015 (now US Patent No. 9,839,703);
14/431,096 is a 371 of PCT/US2013/061712 filed 9/25/2013; and
PCT/US2013/061712 claims benefit to PRO 61705513 filed 9/25/2012.
Note(s): The earliest effective filing date is 9/25/2012 because the pending invention is fully supported in the provisional application.
Applicant’s Election
Once again, Applicant's election without traverse of Group I (previously presented product claims 1-15 and 19 which correspond to pending claims 20-27) filed 6/26/2025 is acknowledged. Hence, the restriction requirement is still deemed proper and is therefore made FINAL.
Applicant elected the species
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conjugated to 177Lu for initial examination. For Applicant’s formula MC-S-P, the variables have the following values: M is 177Lu, C is the chelator DOTA, S is p-Aminobenzylamine-diglycolic acid, and P is DPhe-Gln-Trp-Ala-Val-Gly- His-CO-NH-CH(CH2-CH(CH3)2)2. Applicant further elects a therapeutic radionuclide which is 177Lu, a diagnostic radionuclide which is 67Ga, and cancer of interest is breast cancer.
Initially, Applicant’s elected species was searched and no prior art was found which could be used to reject the claims. However, the claims were amended to exclude the elected species (see amendment filed 3/31/2026) even though they are product claims overlapping with those previously presented.
Election By Original Presentation
Newly submitted claims 28 and 29 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the previously presented and examined claims as well as the elected Group I were directed to product claims (equivalent to pending claims 20-27).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 28 and 29 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Information Disclosure Statement
The information disclosure statement filed 3/31/2026 was considered.
Response to Applicant’s Arguments and/or Amendment
The Applicant's arguments and/or amendment filed 3/31/2026 to the rejection of claims 1-15 and 19 made by the Examiner under 35 USC 112 and/or double patenting have been fully considered and deemed persuasive-in-part for the reasons set forth below.
Double Patenting Rejections
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.
I. Claims 20-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15, 18, and 29-31 of copending Application No. 17/283,462 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to radiolabeled compounds comprising a peptide, chelators, and radiolabeled metal. Thus, both applications disclose overlapping composition components wherein M is 177Lu, 68Ga, or 111In. Hence, the inventions disclose overlapping subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
II. Claims 20-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,839,703. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to radiolabeled compounds comprising a peptide, chelators, and radiolabeled metal. Thus, both applications disclose overlapping composition components wherein M is various metals including 99mTc, 186Re, 67Ga, 177Lu, 68Ga, and 111In, for example. In addition, patented claim 1 is directed to other species which are encompassed by the formula MC-S-P as set forth in pending independent claim 20. Hence, both inventions disclose overlapping subject matter.
III. Claims 1-15 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,064,489. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to compositions which may be conjugated to various metals including 186Re, 188Re, 177Lu, 68Ga, and 164Cu, for example. In addition, patented claim 1 is directed various species encompassed by the formula MC-S-P as set forth in pending independent claim 20. Furthermore, while the patented claim is directed to a method, the compounds used therein are GRPR antagonists and radiolabeled compositions like the pending application. Hence, both inventions disclose overlapping subject matter.
IV. Claims 20-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 7-9 of U.S. Patent No. 12,064,490. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to compositions which may be conjugated to a radioactive metal (e.g., M is 177Lu). In addition, patented claim 1 is directed to various species which are encompassed by the formula MC-S-P as set forth in pending independent claim 20. Hence, both inventions disclose overlapping GRPR antagonists which are radiolabeled compositions encompassed by the pending invention.
V. Claims 20-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 7-9 of U.S. Patent No. 12,064,491. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to compositions that may be conjugated to a metal, M such as 68Ga (see patented claim 2). In addition, patented claim 1 is directed to various species which are encompassed by the formula MC-S-P as set forth in pending independent claim 20. Hence, both inventions disclose overlapping GRPR antagonists which are radiolabeled compositions encompassed by the pending invention.
APPLICANT’S ASSERTIONS
In summary, Applicant has requested that all the double patenting rejections be held in abeyance until allowable subject matter is set forth.
EXAMINER’S RESPONSE
The Examiner acknowledges Applicant’s request to hold the double patenting rejection in abeyance until allowable subject matter is set forth. However, the double patenting rejections are still deemed proper as they are directed to overlapping subject matter.
Written Description Rejection
The 112 first paragraph (written description) rejection is WITHDRAWN because Applicant amended the claims to overcome the rejection.
112 Second Paragraph Rejections
The 112 second paragraph rejections are WITHDRAWN because Applicant amended the claims to overcome the rejections.
NEW MATTER REJECTIONS
New Matter Rejection
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 20-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claim 20 is directed to a radiolabeled compound of formula: MC-S-P wherein M is a radiometal bound to C-S-P;
MC-S-P is
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; P is -DPhe-Gln-Trp-Ala-Val-Gly-His-NH-Z; Z is
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wherein X is NH (amide) and R1 and R2 are independently selected from a proton and an optionally substituted alkyl.
In particular, the variable P is defined as -DPhe-Gln-Trp-Ala-Val-Gly-His-NH-Z wherein Z is
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; X is NH and R1 and R2 are independently selected from a proton and an optionally substituted alkyl. When the variable Z is replaced with
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, it results in
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which has to -NH groups attached to one another. Such a peptide sequence with Z attached thereto have two -NH groups conjugated to one another is not consistent with the disclosure (see page 18, line 6 of the originally filed specification; pages 18, paragraph [002], lines 14 and 30-38 of the substitute specification filed 3/31/2026). Thus, Applicant has incorporated new matter into the pending claims.
Comments/Notes
While no prior art is cited against the pending invention, it should be noted that the claims submitted 3/31/2026 contain new matter as indicated supra. For the claims containing new matter, prior art was not found which could be used to reject the claims.
For clarity of claim 20, it is respectfully suggested that in line 1, the phrase ‘the formula’ be replaced with ‘formula’. In claim 20, line 3, delete ‘of the following formula’.
Conclusion
Claims 20-27 are rejected. Claims 28 and 29 are withdrawn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G. Hartley 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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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
June 4, 2026
Prosecution Insights