DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's amendment and remarks filed on 10/30/2025 are acknowledged.
Claims 1-2 and 5-19 are pending.
Claims 13-19 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/15/2025.
Claims 1-2 and 5-12 are presently under consideration.
3. 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.
4. Claims 2 and 6 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claim 2 is indefinite as being in improper Markush format. The Office recommends the use of the phrase "selected from the group consisting of ..." with the use of the conjunction "and" rather than "or" in listing the species. See MPEP 803.02.
(ii) Claim 12 is indefinite, because the nature of “microbeads” used for activation of Th1-like effector cells is unknown.
Applicant’s amendments to claims 2 and 12 are acknowledged, but fail to address the grounds of rejection presented in the previous office action.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
5. The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
6. Claim 1 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. This is a New Matter rejection.
Applicant does not point out the support for the amendment, and the disclosure as-filed does not appear to provide adequate written description of the following newly added limitation: “administering regorafenib to the patient in alternating doses with the at least one immune checkpoint inhibitor.”
The specification contains the following disclosure:
“For subjects that remain clinically stable, they can advance to an Expansion Phase of continued alternating 2 week dosing of AlloStim® and avelumab (Day 119-Day 161).” ([0098] at p. 16 of the specification as-filed) This passage discloses alternating 2 week dosing of AlloStim® and avelumab, which does not support “administering regorafenib to the patient in alternating doses with the at least one immune checkpoint inhibitor.”
The specification further contains the following disclosure:
“A short and reduced dose of regorafenib was administered at 40 mg bid (80 mg/day total). Regorafenib dose was increased with alternating 40 mg bid (80 mg/day total) and 40 mg tid (120 mg/day total).” ([0113] at p. 21 of the specification as-filed)
“Regorafenib 80 mg day 1 / 120 mg day 2 (alternating)” (Table 1 at p. 22 of the specification as-filed).
These passages disclose alternating different doses of regorafenib, which does not support “administering regorafenib to the patient in alternating doses with the at least one immune checkpoint inhibitor.”
The amended claims now recite limitations which were not clearly disclosed in the specification or claims as filed, and change the scope of the instant disclosure as filed. These limitations introduce new concepts and violate the description requirement of 35 U.S.C. 112(a).
Applicant is required to cancel the New Matter in the response to this Office Action. Alternatively, Applicant is invited to clearly point out the written support for the newly added limitations.
7. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
8. Claims 1-2 and 5-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kananathan et al. (2020) in view of Arai et al. (2019).
The grounds of rejection set forth in section 12 of the previous Office action are maintained for the reasons of record, as they apply to the amended claims.
Applicant’s arguments have been fully considered but have not been found convincing.
Applicant states: “the claims are directed to a method of administering activated allogeneic CD4+ T-cells to a patient; administering at least one immune checkpoint inhibitor to the patient wherein the checkpoint inhibitor targets CTLA-4, PD-1, and/or PD-L1 checkpoint molecules, and then further administering regorafenib to the patient in alternating doses with the at least one immune checkpoint inhibitor.” In Applicant’s description, administration of regorafenib in alternating doses with ICI is a separate step which follows administration of the T cells and ICI. This is not consistent with claim 1 as presently recited, which reads on administering the T cells, ICI, and alternating regorafenib/ICI in any order or simultaneously.
Applicant further argues that the claimed method also assists in distinguishing tumor progression from pseudoprogression using CT scan imaging, referring to paragraphs [0084]-[0086] of the specification. Here Applicant argues a limitation which is not claimed. As a side issue, the cited paragraphs of the specification highlight the difficulty in distinguishing tumor progression from pseudoprogression using CT scan imaging, but do not appear to indicate that the claimed method assists in overcoming this difficulty.
Therefore, the rejection is maintained for the reasons of record, and is incorporated by reference herein as if reiterated in full.
9. Conclusion: no claim is allowed.
10. 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 8:30 AM – 5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Kolker can be reached at 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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