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 .
Response to Amendment
In the amendment filed on 02/26/2026 Applicant amended the claims 1, 10 and 16, and added the new claims 22 and 23. Claims 1-5, 7-12, 16-18 and 22-23 are pending and are examined.
Withdrawn claim rejections
Claim Rejections - 35 USC § 103
The rejection of claim 9 under 35 U.S.C. 103 as being unpatentable over BMSC in view of Mandell and in further view of SSM is withdrawn in view of persuasive arguments of Applicant.
Maintained and new rejections necessitated by amendment
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.
Claims 1-5, 7-12, 16-18 and 22-23 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. Specifically, the meaning of the wording: “ a reference level of p-ERK from a control malignant glioma” is indefinite since it is not clear if the “control” is considered from a patient that does not have malignant glioma or not.
The independent claims 1 and 10 (and their dependent claims) omit dosages and administration regimens and thus they are further indefinite.
Claim Rejections - 35 USC § 103
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, 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.
Claims 1-5, 7-8, 10-12 and 16-18 remain rejected under 35 U.S.C. 103 as being unpatentable over BMSC in view of Mandell et al. (both cited in the previous Office action) for reasons of record.
On page 6 of the Remarks Applicant argues that: “… the cited references, alone or in combination, do not provide a reasonable expectation of success in using a comparison of p-ERK levels between a subject's malignant glioma and a control malignant glioma as an indicator for PD-1 blockade responsiveness.”
The arguments were carefully considered but not found persuasive because, first of all, claims 1-5, do not require an indicator for PD-1 blockade responsiveness. They are drawn, plainly, to a method of treating malignant glioma with a PD-1 or PD-L1 inhibitor, acknowledging that in glioblastoma the p-ERK levels are elevated vs. a healthy subject.
Second, in Table 1 of the reference, Mandel clearly shows that all glioblastoma samples had elevated ERK phosphorylation (> 10%) while ~ 50% of the samples had more than 50% ERK phosphorylation when compared to controls. Thus, a perfectly logical conclusion is that , when elevated levels of pERK are noticed, the patient is highly suspected of having Glioblastoma and would benefit of the treatment with the reagents taught by BMSC.
With regard to the classifying method, Mandel shows that all the glioblastoma samples have an elevated pERK level (Table 1) and thus the “classification” step would be obvious to a person of ordinary skill in the art since BMSC treated glioblastoma with PD-1 or PD-L1 antibodies.
Conclusion
No claims are allowed.
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 ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647