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
1. Claims 1, 7 are amended. Claims 20-22 are withdrawn. Claims 8, 11 are canceled. Claims 1-7, 9, 10, 12-19 are under consideration.
Information Disclosure Statement
2. The information disclosure statement (IDS) was submitted on 10/2/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
3. (new, necessitated by amendment) Claims 1-7, 9, 10, 12-19 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.
See claims 1-7, 9, 10, 12-19 as submitted 10/2/2025.
Amended claim 1 recites “contacting tumor cells of the first tumor only with a chimeric poliovirus … such that the one or more distal tumors are not contacted with the chimeric poliovirus”. It is not clear what “such that” means. It is not clear what is to be done or what steps are be taken to ensure one or more distal tumors are not contacted with the chimeric poliovirus.
Claim Rejections - 35 USC § 103
4. (previous rejection, withdrawn) Claims 1-5, 7, 12, 18, 19 were rejected under 35 U.S.C. 103 as being unpatentable over Gromeier et al. (US20170216382)(cited in applicant’s IDS submitted 5/22/2024) in view of McCarthy et al. (“Developing Picornaviruses for Cancer Therapy,” Cancers 11, 685 (2019)) (cited in applicant’s IDS submitted 5/22/2024).
Applicant contends: Ansardi in McCarthy et al. teaches replication incompetent poliovirus replicons; there are differences between those poliovirus replicons and the claimed chimeric poliovirus; one of ordinary skill in the art would not have had any basis to expect them to function in the same way; the claimed poliovirus has capsid of live attenuated type 1 vaccine; replicons in Ansardi do not encode the poliovirus capsid proteins; by inserting foreign sequences in lieu of the viral capsid ORF, Ansardi interferes with the viral replication cycle; the deletion of the viral capsid ORF and the presence of foreign sequences for the capsid protein in the replicons of Ansardi are major triggers for genetic variability; McCarthy combined with Gromeier does not teach a method as claimed; a skilled person could not have had any reasonable expectation of success.
In view of applicant’s amendments and upon consideration of applicant’s arguments, the rejection is withdrawn.
5. (previous rejection, withdrawn) Claims 6, 13-15 were rejected under 35 U.S.C. 103 as being unpatentable over Gromeier et al. in view of McCarthy et al. as applied to claims 1-5, 7, 12, 18, 19 above, and further in view of Brlic et al. (“Targeting PVR (CD155) and its receptors in anti-tumor therapy,” Cellular & Molecular Immunology, 16: 40-52 (2018); previously cited).
Applicant contends: the other reference does not cure the deficiency.
In view of the withdrawal of the rejection over Gromeier et al. in view of McCarthy et al. on which the instant rejection depends, the instant rejection is also withdrawn.
6. (previous rejection, withdrawn) Claim 9 was rejected under 35 U.S.C. 103 as being unpatentable over Gromeier et al. in view of McCarthy et al. as applied to claims 1-5, 7, 12, 18, 19 above, and further in view of Morrow et al. (U.S. Patent No. 5622705; previously cited).
Applicant contends: the other reference does not cure the deficiency.
In view of the withdrawal of the rejection over Gromeier et al. in view of McCarthy et al. on which the instant rejection depends, the instant rejection is also withdrawn.
7. (previous rejection, withdrawn) Claims 10, 16, 17 were rejected under 35 U.S.C. 103 as being unpatentable over Gromeier et al. in view of McCarthy et al. as applied to claims 1-5, 7, 12, 18, 19 above, and further in view of Bigner et al. (WO2017066557A1; previously cited).
Applicant contends: the other reference does not cure the deficiency.
In view of the withdrawal of the rejection over Gromeier et al. in view of McCarthy et al. on which the instant rejection depends, the instant rejection is also withdrawn.
Conclusion
8. No claims are allowed.
9. 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 M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672