DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 20-46 are pending in the application.
This action is in response to applicants' amendment dated August 26, 2026. Claim 45 has been amended.
Response to Amendment
Applicant's arguments filed August 16, 2026 have been fully considered with the following effect:
With regards to the provisional non-statutory double patenting rejections the Applicants have requested that each be held in abeyance until there is allowable subject matter. The following provisional non-statutory double patenting rejections are herein maintained for reasons of record.
Claims 45 and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 17/052,928 (reference application).
Claims 45 and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of copending Application No. 17/052,925 (reference application).
Claims 45 and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-43 of copending Application No. 17/619,796 (reference application).
Claims 45 and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-11, 15 and 30-33 of copending Application No. 17/619,794 (reference application).
Claims 45 and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-8, 11, 12, 17, 18 and 31-33 of copending Application No. 17/619,791 (reference application).
The applicant's filing of a terminal disclaimer is sufficient to overcome the non-statutory double patenting rejection, labeled paragraph 8) in the last office action, which is hereby withdrawn.
The applicant's amendments and arguments are sufficient to overcome the 35 U.S.C. 102(a)(1), anticipation rejection, labeled paragraph 9) in the last office action, which is hereby withdrawn.
The applicant's amendments and arguments are sufficient to overcome the 35 U.S.C. 102(a)(1), anticipation rejection, labeled paragraph 10) in the last office action, which is hereby withdrawn.
The applicant's amendments and arguments are sufficient to overcome the 35 U.S.C. 102(a)(1), anticipation rejection, labeled paragraph 11) in the last office action, which is hereby withdrawn.
The applicant's filing of a terminal disclaimer is sufficient to overcome the non-statutory double patenting rejection, labeled paragraph 12) in the last office action, which is hereby withdrawn.
The applicant's filing of a terminal disclaimer is sufficient to overcome the non-statutory double patenting rejection, labeled paragraph 13) in the last office action, which is hereby withdrawn.
The applicant's filing of a terminal disclaimer is sufficient to overcome the non-statutory double patenting rejection, labeled paragraph 14) in the last office action, which is hereby withdrawn.
With regards to the non-statutory double patenting rejection as being unpatentable over claims 1-25 of U.S. Patent No. 10,927,139, labeled paragraph 15), in the last office action, the applicants stated the instant claims require MMAE or doxorubicin and that there is nothing in the referenced claims. However, the claims of U.S. ‘139 are directed to the method for provoking the release, in vitro, of a construct wherein the construct is CB which in turn is defined as a small molecule, an organic molecule, a metal coordination compound, an inorganic molecule, an organometallic molecule, a biomolecule, a drug, a polymer, a resin, etc. For example, doxorubicin is the CB in example 9.
Claims 45 and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,927,139, for reasons of record and stated above.
With regards to the non-statutory double patenting rejection as being unpatentable over claims 20-34 of U.S. Patent No. 10,967,069, labeled paragraph 16), in the last office action, the applicants stated the instant claims require MMAE or doxorubicin and that there is nothing in the referenced claims. However, the claims of U.S. ‘069 are directed to the method of administering a drug to a patient comprising administering a drug-dienophile conjugate and an activator. Doxorubicin is an anthracycline and is specifically exhibited in examples 6 and 7. MMAE is a toxin and is specifically exhibited in examples 15, 16, 18 and 19.
Claims 45 and 46 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 20-34 of U.S. Patent No. 10,967,069, for reasons of record and stated above.
With regards to the non-statutory double patenting rejection as being unpatentable over claims 1-41 of U.S. Patent No. 11,617,799, labeled paragraph 17), in the last office action, the applicants stated the instant claims require MMAE or doxorubicin and that there is nothing in the referenced claims. However, the claims of U.S. ‘799 are directed to the method for provoking the release, in vitro, of a construct wherein the construct is CA which in turn is defined as a small molecule, an organic molecule, a metal coordination compound, an inorganic molecule, an organometallic molecule, a biomolecule, a drug, a polymer, a resin, etc. MMAE is a exhibited in examples 15 and 16.
Claims 45 and 46 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-41 of U.S. Patent No. 11,617,799, for reasons of record and stated above.
Election/Restrictions
This application contains claims 20-44 are drawn to an invention nonelected without traverse in the reply filed on December 16, 2025. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Conclusion
THIS ACTION IS MADE FINAL. 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 BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
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, Jeffrey H. Murray can be reached at 571-272-9023. 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.
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
Prosecution Insights