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 .
Election/Restrictions
Claims 6-11, 13, and 14 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group (II and III) and species, there being no allowable generic or linking claim.
Applicant's election with traverse of Group I and the elected species [see Remarks 7/6/2026, Page 30] in the reply filed on 7/6/2026 is acknowledged. The traversal is on the ground(s) that:
“Since Group II is directed to a method of preparing a peptide urea derivative of Formula I and Group III is directed to a use of Formula I, all groups share a single general inventive concept. Accordingly, the Examiner's assertion that the groups of inventions listed above do not relate to a single general inventive concept because they lack the same or corresponding special technical features is therefore without merit.” [Remarks 7/6/2026, Page 31]
This is not found persuasive because 37 CFR 1.475(b) does not override the requirement of a technical relationship among those inventions outlined in 37 CFR 1.475(a).
37 CFR 1.475(a) states “Where a group of inventions is claimed in an application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features.” The present application is drawn to 3 different inventions (a product, a process specially adapted for the manufacture of the said product, and a use of said product). Accordingly, the group of inventions must have a technical relationship among them to satisfy the requirement of unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Withdrawn: 6-11, 13, 14
Examined Herein: 1-5, 12
Priority
Acknowledgment is made of applicant's claim for priority under based upon an application filed in CN202111031423.6 on 9/3/2021, PCT/CN2022/116897 ON 9/2/2022 and US 18/776,861 (Patent 12,427,211) on 7/18/2024. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/2/2024, 5/21/2024, 1/22/2025, and 7/6/2026 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 received on 3/15/2024 are accepted.
Claim Rejections - 35 USC § 102
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bohnke (US 2023/0072421 A1, Filed 7/24/2020).
With respect to claim 1, Bohnke discloses the following compound:
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685
912
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[Bohnke, 1271]
wherein:
L is L1-L2
L1 is a 6-membered heteroaromatic ring, pyridine, substituted by R1-2; wherein:
In the heteroaromatic ring, the number of heteroatoms is 1
The heteroatom is N
R1-2 is a C1 alkyl (methyl)
L1 is linked to R through an N atom
L2 is a bond
L2 is linked to
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158
405
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R is a group containing a radioactive metal ion, DOTA, thus meeting the limitations of claim 1. [Bohnke, 1271]
With respect to claim 2, Bohnke discloses the following conditions, thus meeting the limitations of claim 2: [Bohnke, 1271]
L1 is a monocyclic ring (Condition 4)
In L1, the number of heteroatoms in the 5-12 membered heteroaromatic ring is 1 (Condition 8)
The C1-C3 alkyl is methyl (Condition 20)
The group containing a radioactive metal ion is composed of a radioactive metal ion (Th-227) and a group with the function of chelating a metal ion (DOTA), wherein the radioactive metal ion is chelated with the group with the function of chelating a metal ion (Condition 21)
The radioactive metal ion (Th-227) is a radioactive metal ion releasing α rays (Condition 24)
The radioactive metal ion has one of the following effects: 3. radiation treatment (Condition 25)
The radioactive metal ion has one or more of the following effects: 1. tracking; 2. delivery (Condition 26)
With respect to claim 3, Bohnke discloses the following conditions, thus meeting the limitations of claim 3: [Bohnke, 1271]
The group with the function of chelating a metal ion is DOTA (Condition 2)
L2 is a bond (condition 4)
With respect to claim 4, Bohnke discloses the following conditions, thus meeting the limitations of claim 4:
The group with the function of chelating a metal ion is DOTA (Condition 2)
L2 is a bond (Condition 4)
With respect to claim 12, Bohnke discloses a pharmaceutical composition comprising the aforementioned compound and a pharmaceutical adjuvant (PABA, sodium acetate buffer, and EtOH), thus meeting the limitations of claim 12. [Bohnke, 1272]
Allowable Subject Matter
Claim 5 would be allowable over the prior art if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 1-5 and 12 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,427,211 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a compound encompassed by instant Formula I. As a result, the entire scope of the reference claim falls within the scope of or overlaps with the instant claims. Thus, the present invention discloses overlapping subject matter with the reference claims, and granting a patent to the present application would give rise to an unjustified extension of the rights granted in the reference patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAILA A CRAIG whose telephone number is (703)756-4540. The examiner can normally be reached Monday-Friday 0800-1600.
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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