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 .
Claims Status
Claims 1, 2, & 6-9 filed on 08/14/2026 are pending. Claim 10 is withdrawn from consideration as being drawn to a non-elected invention. Claims 1-10 are currently under examination directed to the elected species the combination of -173C and -794 CATT5-8 in claims 1-10 and of -173G/C in claim 2 (see response dated 02/18/2026). The cancellation of claims 3-5 without prejudice in the reply filed 08/14/2026 is acknowledged. All the amendments and arguments have been thoroughly reviewed but are deemed insufficient to place this application in condition for allowance. The following rejections are either newly applied, as necessitated by amendment, or are reiterated. They constitute the complete set being presently applied to the instant application. Response to Applicant’s argument follow. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Any rejection not reiterated is hereby withdrawn in view of the amendments to the claims.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, & 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piette (Piette et al.; The Journal of Biochemistry, Vol. 284, pages 32483-32492, November 2009), as cited in the IDS dated 10/08/2024, in view of Wilcox (Wilcox, Ramakrishna, & Magge; World Neurosurgery, Vol. 116, pages 518-528, August 2018).
Regarding amended claim 1, Piette teaches a method of measuring two MIF promoter polymorphisms in human glioblastoma cells (sample from a subject having symptoms of glioblastoma) comprising measuring -173 G to C transition and seven copies of the -794 CATT repeat polymorphisms with 6 CATT repeats measured (nucleic acid detection assay detects the presence of MIF promoter region of polymorphism selected from -173C and -794 6 CATT repeat) and further treating the cell with dexamethasone (treating the subject) (abstract lines 1-27; pg. 32484 column 1 2nd full paragraph lines 1-14; pg. 32484 paragraph bridging column 1 & 2 lines 1-9; pg. 32485 column 2 2nd full paragraph lines 1-12; pg. 32487 column 1 1st full paragraph lines 1-10; pg. 32487 paragraph bridging column 1 & 2 lines 1-12; Table 2).
Piette does not teach treating the subject with an immune checkpoint inhibitor or a CAR-T cell therapy for glioblastoma.
Wilcox teaches treatment of glioblastoma in subjects with a variety of therapeutics comprising treatment of glioblastoma with immune checkpoint inhibitors pembrolizumab, ipilimumab, and nivolumab (abstract lines 1-15; pg. 520 paragraph bridging column 1 & 2 lines 1-6; pg. 521 column 1 1st full paragraph lines 1-6). Wilcox also teaches that treatment of glioblastoma with immune checkpoint inhibitors comprising pembrolizumab, ipilimumab, and nivolumab provide a successful cancer immunotherapy through balancing activating and inhibitory signals on T-cell activation while minimizing host tissue damage (pg. 520 paragraph bridging column 1 & 2 lines 1-6; pg. 521 column 1 1st full paragraph lines 1-6).
Piette and Wilcox are considered to be analogous to the claimed invention because they are all in the same field of treatment of glioblastoma. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of measuring two MIF promoter polymorphisms in human glioblastoma cells (sample from a subject having symptoms of glioblastoma) comprising measuring -173 G to C transition and seven copies of the -794 CATT repeat polymorphisms with 6 CATT repeats measured and further treating with an immune modulating therapy in Piette to incorporate the treatment of glioblastoma with an immune checkpoint inhibitor comprising pembrolizumab as taught in Wilcox because Wilcox teaches that doing so would provide a successful cancer immunotherapy through balancing activating and inhibitory signals on T-cell activation while minimizing host tissue damage.
Regarding claim 2, Piette teaches the -173 G/C single nucleotide polymorphisms is -173G/C (subjects genotype is determined to be -173G/C) (pg. 32485 column 2 2nd full paragraph lines 1-12; pg. 32487 column 1 1st full paragraph lines 1-10; Table 2).
Regarding amended claim 6, Piette teaches Piette teaches measuring seven copies of the -794 CATT repeat (-794 CATT7) when measuring a MIF promoter polymorphism (pg. 32485 column 2 2nd full paragraph lines 1-12; pg. 32487 column 1 1st full paragraph lines 1-10; Table 2).
Regarding claim 7, Piette teaches detecting the MIF promoter polymorphisms on -173 G/C and -794 CATT repeats through nucleotide sequencing (detecting is conducted by a method of sequencing) (pg. 32487 column 1 1st full paragraph lines 1-10).
Regarding amended claim 8, Piette teaches a method of measuring two MIF promoter polymorphisms in human glioblastoma cells (sample from a subject having symptoms of glioblastoma) comprising measuring -173 G to C transition and seven copies of the -794 CATT repeat polymorphisms with 6 CATT repeats measured (receiving results from said nucleic acid detection assay) (abstract lines 1-27; pg. 32484 column 1 2nd full paragraph lines 1-14; pg. 32484 paragraph bridging column 1 & 2 lines 1-9; pg. 32485 column 2 2nd full paragraph lines 1-12; pg. 32487 column 1 1st full paragraph lines 1-10; pg. 32487 paragraph bridging column 1 & 2 lines 1-12; Table 2).
Regarding amended claim 9, Wilcox teaches treatment of glioblastoma in subjects with a variety of therapeutics comprising treatment of glioblastoma with immune checkpoint inhibitors pembrolizumab, ipilimumab, and nivolumab (abstract lines 1-15; pg. 520 paragraph bridging column 1 & 2 lines 1-6; pg. 521 column 1 1st full paragraph lines 1-6).
Response to Arguments
The response traverses the rejection. The response asserts that Piette does not teach or suggest treating a subject with an immune checkpoint inhibitor or a CAR-T cell therapy, as now recited in amended claim 1. Further, the response asserts that Piette instead discloses treating cultured glioma cell lines with dexamethasone, a corticosteroid that acts through a wholly different, and largely opposing mechanism that the immunotherapies recited in the claims. Further, the response asserts the dexamethasone is an immunosuppressive rather that an immune-activating agent and is not an immune checkpoint inhibitor which blocks inhibitory receptors such as PD-1 or CTLA-4 and therefore these are distinct classes of agent with distinct mechanisms of action, regulatory approval pathways, and clinical uses and for at least these reasons, Piette fails to disclose each and every element of amended claim 1. This argument has been thoroughly reviewed but was not found persuasive as the combination of Piette and Wilcox, as applied to claim 1 as necessitated by amendment, teach all of the limitations of the currently pending independent claim 1, and dependent claims 2 & 6-9, as discussed further above.
For these reasons, and the reasons already made of record and modified to address the claims as currently amended, the rejections are maintained and applied to the newly amended claims.
Conclusion
Claims 1, 2, & 6-9 are rejected.
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 BAILEY C BUCHANAN whose telephone number is (703)756-1315. The examiner can normally be reached Monday-Friday 8:00am-5:00pm ET.
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/BAILEY BUCHANAN/Examiner, Art Unit 1682
/JEHANNE S SITTON/Primary Examiner, Art Unit 1682
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