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 .
DETAILED ACTION
Restriction/Election
1. Applicant’s election without traverse of Group I (claims 1-19) in the reply filed on 08/11/2026 is acknowledged. In response to species election requirement, Applicants elected (i) chenodeoxycholic acid (CDCA) and (ii) V40 NLS (SEQ ID NO: 1).
2. Claims 1-20 are pending. Claims 1-19 are under consideration. Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Information Disclosure Statement
3. The information disclosure statement filed on 03/21/2024 and 12/27/2023 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to the office action.
Drawings
4. The drawings filed on 12/19/2023 are accepted by the Examiner.
Claim Rejections[Symbol font/0xBE] Nonstatutory Obviousness-Type Double Patenting
5. Basis for nonstatutory 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. See 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);and, 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/ guidance/eTD-info-I.jsp.
6. Claims 1-19 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of US Patent No. 11,890,350 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1-20 of US Patent No. 11,890,350 B2 are drawn to a pharmaceutical composition comprising a bile acid-peptide conjugate as a cytotoxic or cytostatic agent, the conjugate being free or releasably bound to a carrier molecule and being present in the pharmaceutical composition at an effective concentration of at least 40 micromolar, wherein the peptide comprised in the bile acid-peptide conjugate comprises a nuclear localization signal (NLS), wherein the bile acid-peptide conjugate when releasably bound to the carrier molecule is bound via an enzymatically cleavable linker, a photocleavable linker, a redox-sensitive linker, or a pH-sensitive linker, and wherein the carrier molecule is not a polypeptide antigen.
On the other hand, claims 1-19 of the instant application are drawn to a pharmaceutical composition comprising a steroid acid-peptide conjugate, the conjugate being free or releasably bound to a carrier molecule and being present in the pharmaceutical composition at an effective concentration sufficient to induce cytostasis or cytotoxicity, wherein the peptide comprised in the steroid acid-peptide conjugate comprises a nuclear localization signal (NLS), and wherein the carrier molecule is not a polypeptide antigen. Claims 1-20 of US Patent No. 11,890,350 B2 and claims 1-19 of the instant application vary in scope and are obvious over each other.
7. Claims 1-19 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 5, 7-8, 10-11, 16, and 19 of copending Application No. 18/717,506. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1, 5, 7-8, 10-11, 16, and 19 of copending Application No. 18/717,506 are drawn to a composition comprising a steroid acid-peptide conjugate covalently linked to and/or admixed with a cargo for intracellular delivery, wherein the peptide comprises a nuclear localization signal and the cargo is or comprises a protein, peptide, polynucleotide, polynucleotide analog, polysaccharide, drug, or any combination thereof, and wherein: (a) the cargo does not bind specifically to a cell surface receptor or ligand; (b) the cargo is not an antibody, and (c) the cargo is not or does not comprise an antigen.
On the other hand, claims 1-19 of the instant application are drawn to a pharmaceutical composition comprising a steroid acid-peptide conjugate, the conjugate being free or releasably bound to a carrier molecule and being present in the pharmaceutical composition at an effective concentration sufficient to induce cytostasis or cytotoxicity, wherein the peptide comprised in the steroid acid-peptide conjugate comprises a nuclear localization signal (NLS), and wherein the carrier molecule is not a polypeptide antigen.
It is noted that claims 1, 5, 7-8, 10-11, 16, and 19 of copending Application No. 18/717,506 use the term “cargo”, whereas 1-19 of the instant application use the term ‘carrier”. Claims 10 and 17 of the instant application limit the carrier to a protein carrier; a polysaccharide carrier; a polynucleotide carrier; a polynucleotide analog carrier; a polyethylene glycol carrier; or a lipid carrier. Thus, claims 1-19 of the instant application and claims 1, 5, 7-8, 10-11, 16, and 19 of copending Application No. 18/717,506 vary in scope and are obvious over each other.
Conclusions
8. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674 August 24, 2026
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