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 .
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 23 January 2026, has been entered.
Election/Restrictions
Applicants canceled all nonelected Group II claims drawn to methods of use of the elected Group I claims before rejoinder could occur.
Therefore, the Office is maintaining the Restriction Requirement of 24 June 2024 to preserve Applicants’ rights under 35 USC 121. See MPEP 821.04(b).
The Election of Species Requirement of 24 June 2024 is withdrawn, as all pending claims are free of the prior art.
Current Status of 18/530,467
This Office Action is responsive to the amended claims of 23 January 2026.
Claims 1-9 and 21-25 have been examined on the merits. Claims 5 and 21 are currently amended. Claims 1, 3-4, and 22-25 are previously presented. Claims 2 and 6-9 are original.
Priority
The effective filing date is 21 October 2017.
Response to Arguments
The Examiner acknowledges receipt of and has reviewed Applicants’ claim amendments and Reply of 23 January 2026.
The non-statutory double patent rejection against co-pending reference 16/343,732 (see paragraph 23 of the previous Office Action) is withdrawn since 16/343,732 has been abandoned.
The claim objections of paragraph 26 (previous Office Action) is withdrawn.
The claim objection of paragraph 27 is withdrawn due to Applicants’ claim amendments.
The various Terminal Disclaimers submitted by Applicants on 23 January 2026 were each disapproved by Office of Patent Legal Administration (OPLC).
Each of the 4 TDs:
Has the incorrect registration number for signing attorney; and
The Power of Attorney has not been accepted: the Party who is giving Power of Attorney has not been identified. Please note the N572 form for the reason for non-acceptance.
Please resubmit each of the 4 TDs for each of the references (non-statutory double patent rejections maintained and reproduced, below). No fee is required to resubmit each of the 4 TDs.
Contact Trina Steptoe (OPLC) at (571) 272-2577 for specific questions regarding the reason each TD was disapproved.
Thus, the non-statutory double patent rejections are maintained (and reproduced, below).
Double Patenting (Maintained 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.
Claims 1-9 and 21-22 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,878,000 B2. The instant claims of 23 January 2026 were used to write this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims. For example, reference claim 1, drawn to (a method of use of) a sensitizer compound of FI or FII in which the amide of FI or the ester of FII is conjugated to one of: artemisinin, a statin, or a platin-based anti-neoplastic drug, anticipates instant claim 1, drawn to the same sensitizer compound.
Applicants’ claim 1 and 5 amendments adding the disclaimer if the sensitizer is cisplatin, does not render moot this rejection since there are other species (besides cisplatin) of the genus “platin-based anti-neoplastic drug” and of course, reference claims 1 and others anticipate the “statin” and “artemisinin” of instant claim 1, all of which are not disclaimed.
Furthermore, reference col. 2 contains the same platin drug species as/hence anticipates instant claim 3. Reference col. 3, drawn to “pharmaceutical compositions” thereof with “carriers”, anticipates instant claim 5.
Reference claim 3, drawn to simvastatin, artemisinin, or cisplatin, anticipates instant claim 4, drawn to same.
The method of reference claim 1 anticipates the properties/functions (“adapted to”) of instant claim 6.
The method of use of the kit of reference claim 11 anticipates the kit of instant claim 7.
Reference claim 4 drawn to the TKIs, anticipates instant claim 8, drawn to same.
The conjugate pairings of sensitizer compounds with drug AND either gefitinib or icotinib of reference claims 6-7, anticipates instant claim 9, drawn to same.
Reference claim 8, drawn to DZI-SIM ester or amide sensitizer, at least anticipates new claim 22, drawn to same.
Please file a Terminal Disclaimer (TD) to render moot this rejection.
Claims 1-6 and 21-22 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,121,510 B2. The instant claims of 23 January 2026 were used to write this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims. For example, the reference claim 1, drawn to a sensitizer compound of FI or FII in which the amide of FI or the ester of FII is conjugated to one of: simvastatin (species of instant claim 1’s “a statin”), artemisinin, or a statin anticipates instant claim 1, drawn to the same sensitizer compound.
Applicants’ claim 1 and 5 amendments adding the disclaimer if the sensitizer is cisplatin, does not render moot this rejection since there are other species (besides cisplatin) of the genus “platin-based anti-neoplastic drug” and of course, reference claims 1 and others anticipate the “statin” and “artemisinin” of instant claim 1, all of which are not disclaimed.
Furthermore, reference col. 3 contains the same platin drug species as/hence anticipates instant claim 3.
Reference claim 2, drawn to simvastatin and artemisinin, anticipates instant claim 4, drawn to same.
Reference claim 4, drawn to “pharmaceutical compositions” thereof with “carriers”, anticipates instant claim 5.
Reference claim 6 anticipates the instant claim 6 (note the alternative embodiments demarcated by “or”).
Furthermore, reference claim 8 anticipates the DIZ-Simvastatin of new instant claim 22.
Please file a Terminal Disclaimer (TD) to render moot this rejection.
Conclusion
Claims 23-25 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.
Claims 1-9 and 21-22 are not presently allowable as written.
Claims 1 and 5 are free of the prior art for the rationale stated within paragraphs 31-33 of the Final Office Action mailed 24 July 2025.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625