DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed March 17, 2026. Currently, claims 1-2 are pending.
Election/Restrictions
Applicant's election without traverse of anti-PD-1 in the paper filed March 17, 2026 is acknowledged.
Upon further consideration, the election of species has been withdrawn.
Priority
This application claims priority to provisional application 63/369,982, August 1, 2022. It is noted the provisional application does not contain all the subject matter of the instant specification.
Drawings
The drawings are not acceptable.
MPEP 608.02, part VIII states:
Color drawings and color photographs are not accepted in utility applications filed under 35 U.S.C. 111 unless a petition filed under 37 CFR 1.84(a)(2) or (b)(2) is granted. Color drawings and color photographs are not permitted in international applications (see PCT Rule 11.13 ).
Unless a petition is filed and granted, color drawings or color photographs will not be accepted in a utility patent application filed under 35 U.S.C. 111. The examiner must object to the color drawings or color photographs as being improper and require applicant either to cancel the drawings or to provide substitute black and white drawings.
The drawings filed are in color. No petition has been filed.
The black and white drawings on file are illegible. The type can not be read.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Pages 33-36 of the specification contain a list of references.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin et al. (J. Cell Mol. Med. Vol. 25, pages 10111-10125, September 2021).
Lin teaches mutational profiling of low-grade gliomas to identify immunotherapy-related biomarkers (abstract). Lin teaches the tumor immune dysfunction and exclusion (TIDE) algorithm was used to indicate the characteristics of gliomas that respond to immune checkpoint blockage (ICB) therapy(abstract). Lin teaches TIDE algorithm uses a set of gene expression markers to evaluate the mechanism of tumor immune escape. High TIDE score indicates bad curative effect of ICB and shorter survival time after ICB treatment in patients (para 2.7). Lin teaches high expression of ARID1A had lower compared with low expression of ARID1A. Figure S7 illustrates TIDE signatures predict ICB immunotherapy response.
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The figures illustrate responders and non-responders for different subtypes. The TIDE scores in IDH1 and TP53 mutant groups were significantly lower than that in wildtype IDH1 and TP53 groups (para 3.10). Lin teaches not treating subjects with high TIDE scores ICB.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Teng et al. (Frontiers in Immunology, Vol. 13, Article 899710, May 2022).
Teng teaches analysis of expression of genes using CGGA and GTEx database to study different subtypes of LGG. Teng teaches tumor mutational burden and tumor methylation burden in the high-and low-risk groups were analysis which indicated higher gene mutation burden and lower DNA methylation level in the high-risk group (abstract). Teng teaches the gene signature model not only has good universality and stability in predicting tumor prognosis but also for predicting tumor response to immunotherapy. The immunotherapy research downloaded the IMvigor210 dataset and evaluated the predictive power of the risk score for immunotherapy (PD-1) response and PD-L1 blockade. Figure 10G illustrates the response to treatment between the low and high tumor recurrence factor risk score. Analysis of the data of immunotherapy effect in the database revealed that the low-risk score group had a better response to immunotherapy than that in the high-risk score group (Figure 10G).
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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.
Claims 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (Neuro-Oncology, Vol. 25, No. 1, pages 68-81, June 18, 2022).
It is noted the instant publication is Applicant’s own work.
Liu teaches analysis of cellular morphometric subtypes in lower-grade gliomas (LGG). Cellular morphometric biomarkers (CMBs) were identified from TCGA-LGG cohort. Liu teaches important immunotherapy-related biomarkers were identified using IHC (abstract). Supplementary Figure 6 illustrates TCGA-LGG patients within high and low cellular morphometric biomarker groups show significant differences with important biomarkers for immunotherapy. Liu teaches the results indicated mechanisms for immune escape or immune tolerance in subtype 2 tumors which could explain the poor prognosis of subtype 2 patients and lays the foundation of potential immunotherapy for LGG patients (page 79, col. 1). Liu suggests the analysis raises the possibility that subtype 2 LGG patients could benefit from anti-PD-1 immunotherapy.
Liu does not teach treating subtype 2 LGG patients with an immunotherapy, however, Liu explicitly suggests subtype 2 LGG patients could benefit from the therapy. The ordinary artisan would be motivated to have performed the analysis Liu teaches performing to determine LGG subtype 2 patients should be treated with immunotherapy, particularly anti-PD-1 therapy.
Conclusion
No claims allowable over the art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Miao et al. (Frontiers in Genetics, Doi: 10.3389/fgene.2022.951239, September 12, 2022) teaches machine learning identification of subtypes to aid in prognosis assessment and immunotherapy response prediction in low-grade glioma.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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, Wu-Cheng Winston Shen can be reached on (571)272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
June 3, 2026
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