DETAILED ACTION
This Office action details a final action on the merits for the above referenced application No. Claims 1, 5-9, 11, 19, 21, 25, 27-28, and 30 are pending in this application.
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 .
Status of Claims
Claims 1, 27-28, and 30 are amended. Claims 2-4, 10, 12-18, 20, 22-24, 26, 29, and 31-33 are cancelled.
Response to Amendment
The claim amendments filed on 6 Jul. 2026 have been entered.
Response to Arguments
In view of Applicants amendments, the object to claim 16 because of minor informalities is withdrawn.
In view of Applicants amendments, the rejection of claims 1, 5-10, 12,16, 21, and 25 under 35 USC 103 as being unpatentable over Ndinguri et al. (US 2017/0157263 A1; published 8 Jun. 2017), in view of Babich et al. (WO 2013/103813 A1; published 11 Jul. 2013) is withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 5-9, 11, 21, 25, and 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ndinguri et al. (US 2017/0157263 A1; published 8 Jun. 2017), in view of Babich et al. (WO 2013/103813 A1; published 11 Jul. 2013), in further view of Lane et al. (Nucl. Med. Biol.; published 2008) and Jamous et al. (Nucl. Med. Biol.; published 2014) for the reasons cited in the Office action filed on 5 Mar. 2026.
Claim(s) 1, 5-9, 19, 21, 25, 27, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ndinguri et al. (US 2017/0157263 A1; published 8 Jun. 2017), in view of Babich et al. (WO 2013/103813 A1; published 11 Jul. 2013), and Lane et al. (Nucl. Med. Biol.; published 2008), in further view of Dapueto et al. (Bioorg. Med. Chem.; published 2015) for the reasons cited in the Office action filed on 5 Mar. 2026.
Applicants Arguments
Applicants assert that the combination of references fails at least because the basis for combining such references fails in view of claim 1. The tridentate structures of Babich are not diethylenetriamine. The cited structure (Re-(7)) in table 2 of Babich has a completely distinct tridentate structure. The tridentate structure of Lane comprises 99mTc and NOT the rhenium species. There is no reason to incorporate any of the teachings of Lane. Jamous and Dapueto fail to overcome the deficiencies of Ndinguri, Babich, and Lane.
Applicant's arguments filed 6 Jul. 2026 have been fully considered but they are not persuasive. The combination of Ndinguri, Babich, and Lane teach, suggest and motivate all of the limitations of claim 1 as amended including a LHRH peptide of SEQ ID NO: 2; an amino alkyl carboxylic acid linker with an alkyl between 1 and 25 carbons in length covalently bound to X3; a diethylenetriamine tridentate structure; and a metal such as 188Re. Regarding the LHRH peptide composition, Ndinguri provides the claimed LHRH peptide of SEQ ID NO: 2 having an alkyl carboxylic acid linker attached to dLys (instant X3) and a bidentate structure optionally comprising Pt. Ndinguri explains that the Pt-LHRH conjugate targets and binds to the LHRH receptors of any cancer cell or any tumor microenvironment that expresses theses receptors and achieves more effective concentrations of the platinum drug or derivative therapeutic agent in the target area. Like Ndinguri, Babich teaches specific tumor receptor honing bioactive molecules covalently tethered to one of Pt, 186Re, 188Re, and 99mTc using a tridentate chelator. Accordingly, a person of ordinary skill in the art would have understood a tridentate structure comprised of 3 amines to be advantageous since in addition to linking Pt to a tumor receptor honing bioactive molecule, it additionally enables linking 186Re, 188Re or 99mTc to the specific tumor receptor honing bioactive molecule for radiotherapy and/or imaging. The cited compounds 7 and Re-(7) use an amino alkyl carboxylic acid linker wherein the alkyl is of about 11 carbons in length. Similar to Ndinguri and Babich, Lane teaches a specific tumor receptor honing bioactive molecule covalently tethered to a chelator, namely diethylenetriamine. While Lane exemplifies a 99mTc chelated diethylenetriamine comprised of three amines, a person of ordinary skill in the art would have understood from Babich and the knowledge of one or ordinary skill in the art that diethylenetriamine chelator is capable of chelating Pt, 186Re and 188Re whereby enabling (radio)therapy. A recognized advantage is the strongest reason to combine. The cited compounds in Lane use an amino alkyl carboxylic acid linker that is of about 1 carbon in length. It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the composition of Ndinguri by substituting the linker, bidentate structure, and metal with an amino alkyl carboxylic acid linker, diethylenetriamine tridentate structure, and 186Re or 188Re metal as taught by Lane and Babich because the substituting would have been expected to advantageously enable treating cancer cells expressing LHRH receptors or any tumor microenvironment that expresses these receptors by achieving more effective concentrations of 186Re or 188Re in the target area using a stable and therapeutically effective LHRH receptor conjugate. Jamous teaches and motivates linker comprising PEG to advantageously enhance pharmacokinetic properties. Dapueto teaches and motivates dimer complexes including those of instant formula III to advantageously provide extremely stable radiometal complexes formed in high yield in to enabling multivalency and specificity for the LHRH receptor.
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, 5-9, 11, 19, 21, 25, 27-28, and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,130,717 B2, in view of Babich et al. (WO 2013/103813 A1; published 11 Jul. 2013), Lane et al. (Nucl. Med. Biol.; published 2008), Jamous et al. (Nucl. Med. Biol.; published 2014) and Dapueto et al. (Bioorg. Med. Chem.; published 2015) for the reasons cited in the Office action filed on 5 Mar. 2026.
Claims 1, 5-9, 11, 19, 21, 25, 27-28, and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,197,888 B2, in view of Babich et al. (WO 2013/103813 A1; published 11 Jul. 2013), Lane et al. (Nucl. Med. Biol.; published 2008), Jamous et al. (Nucl. Med. Biol.; published 2014) and Dapueto et al. (Bioorg. Med. Chem.; published 2015) for the reasons cited in the Office action filed on 5 Mar. 2026.
Claims 1, 5-9, 11, 19, 21, 25, 27-28, and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,152,089 B2, in view of Babich et al. (WO 2013/103813 A1; published 11 Jul. 2013), Lane et al. (Nucl. Med. Biol.; published 2008), Jamous et al. (Nucl. Med. Biol.; published 2014) and Dapueto et al. (Bioorg. Med. Chem.; published 2015) for the reasons cited in the Office action filed on 5 Mar. 2026.
Applicants Arguments
Applicants assert that the above combinations are non-obvious for at least the same reasons articulated with regards to 35 USC 103 addressed supra.
Applicant's arguments filed 6 Jul. 2026 have been fully considered but they are not persuasive. Each of the ‘717, ‘888, and ‘089 patents claim the LHRH receptor conjugates discussed above in Ndinguri. Babich, Lane, Jamous, and Dapueto are not deficient for the reasons discussed above and the reasons cited in the Office actions filed on 5 Mar. 2026
New Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11, 27-28, and 30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In this case, instant claim 11 is dependent to cancelled claim 10 rendering the claim indefinite. In the case that is amended to be dependent to claim 1. Each of claims 27-28 and 30 comprise a structure comprising a ()n; however the claims have been amended to remove the definition of n and claim 1 has been amended so that linker comprises an amino alkyl carboxylic acid wherein the alkyl is of between 1 and 25 carbons in length. Since n is not defined in any of claims 1, 27-28 and 29, the meaning of the ()n as shown in those structures is not understood. In addition, formula II in claim 28 comprises a mPegn wherein the mPegn is not understood and therefore indefinite.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN R DONOHUE whose telephone number is (571)270-7441. The examiner can normally be reached on Monday - Friday, 8:00 - 5:00 EST.
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 Hartley can be reached on (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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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618
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