DETAILED 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 9, 2025, has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I and species Compound 168 in the reply filed on December 11, 2024, is acknowledged.
Claims 31-33 (Group II) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections - withdrawn
The previous objections are withdrawn in view of the amendment filed November 19, 2025.
Claim Rejections - 35 USC § 112(b)
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.
The previous grounds of rejection are withdrawn in view of the amendment filed November 19, 2025. However, a new grounds of rejection is made necessitated by amendment.
Claims 1, 14, and 18-30 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 claim 1 the indefinite language is: “optional Y”. The language is indefinite because it is not clear from the structural formula that Y is optional. It is not clear how Y is defined when –[Z-R2]m is H. As a result the metes and bounds of formula I are indefinite.
Dependent claims 14 and 18-30 fail to resolve these issues and are likewise rejected.
Claim Rejections - 35 USC § 112(d) - withdrawn
The rejections of the claims under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, are withdrawn in view of the amendment filed November 19, 2025.
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.
In the response filed July 18, 2025, Applicant requested that the following rejections be held in abeyance. The rejections are modified to reflect the amendments to the claims but are otherwise maintained.
Claims 1 and 18-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 19, 21-22, 24, and 27-36 of copending Application No. 18/580,926 (reference application) in view of Bellesoeur et al. (“Axitinib in the treatment of renal cell carcinoma: design, development, and place in therapy,” Drug Design, Development and Therapy 2017:11 2801–2811). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claim 1 recites Formula II-P-2 which falls within formula I of instant claim 1. In this formula R1 is defined as an anti-inflammatory, an immunomodulating, a nephro-protective, and a compound possessing an activity or capable of inducing an activity that modulates gluococorticoid receptor (GR) activity, or reduces the levels of proteinuria/creatinine, or modulates a cytokine release, or otherwise exhibits a biological activity against inflammation-associated kidney diseases, or a kidney injury.
By way of example, in reference claim 14, the structure:
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corresponds to a compound of formula I wherein A1-A7 is cyclo[Dab-Dab-D-Phe-Leu-Dab-Dab-Thr] of polymyxin B nonapeptide; h, i, j, and k are 0; X is C(=O)(CH2)7C(=O)A, l is 1, Z-R2 is absent (m is 0), and Y is absent. The reference claimed structure differs from formula I at position R1 which is
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.
It would have been obvious to substitute axitinib for the R1 group of Formula II-P-2. It would have been obvious to do so given that Bellesoeur et al. teach that axitinib is effective and approved for the treatment of renal cell carcinoma, which is a kidney disease or injury (abstract).
The result compound would satisfy all of the structural limitations of claims 1 and 18-30. The functional limitations are inherent to the structure.
Claims 15-17 and 34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 18, 20, 22, 24, 27-28, and 31-35 of copending Application No. 18/580,921 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
By way of example, in reference claim 14, the last structure is the same as compound 150 in claim 15 and the first structure in instant claims 16 and 34:
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By way of example, in reference claim 14, the first structure on page 22 of the reference claims is an obvious variant of the first structure in instant claim 17:
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The structure is an obvious variant because the only difference is the connectivity of a glutamic acid in the group connecting the drug to the polymyxin. In the reference claim the connectivity is via an alpha carboxyl whereas in the instant claim the connectivity is via a gamma carboxyl.
Claims 1 and 18-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 22-27, and 30 of copending Application No. 19/148,405 (reference application) in view of Bellesoeur et al. (“Axitinib in the treatment of renal cell carcinoma: design, development, and place in therapy,” Drug Design, Development and Therapy 2017:11 2801–2811). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claim 14 recites compounds closely related to formula I of instant claim 1. In this application, the compounds are intended for the treatment of renal disease (claim 25).
By way of example, in reference claim 14, the structure:
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corresponds to a compound of formula I wherein A1-A7 is cyclo[Dab-Dab-D-Phe-Leu-Dab-Dab-Thr] of polymyxin B nonapeptide; h, i, j, and k are 0; X is C(=O)(CH2)2CH(NH2)C(=O)A, l is 1, Z-R2 is absent (m is 0), and Y is absent. The reference claimed structure differs from formula I at position R1 which is
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.
It would have been obvious to substitute axitinib for the R1 group in the reference claim. It would have been obvious to do so given that Bellesoeur et al. teach that axitinib is effective and approved for the treatment of renal cell carcinoma, which is a kidney disease or injury (abstract).
The result compound would satisfy all of the structural limitations of claims 1 and 18-30. The functional limitations are inherent to the structure.
Allowable Subject Matter
Claims 5-7 and 9-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Citation of Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hamill et al. (US 2018/0099022 A1) teach the use of polymyxin B compounds as transporters for intracellular delivery of cargo. However, Hamill et al. do not teach or suggest the delivery of axitinib, brivanib, sunitinib, pazopanib, and semaxanib; or
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or other agents for treating kidney or renal cancer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MARCHETTI BRADLEY whose telephone number is (571)272-9044. The examiner can normally be reached Monday-Friday, 7 am - 3 pm.
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, Lianko G Garyu can be reached on (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA BRADLEY/Primary Examiner, Art Unit 1654