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
Applicant’s election filed March 9, 2026, without traverse of Group I, is acknowledged and has been entered.
Claims 1-6, 15, 17, 28, 30, 38, 40, 42, 55-56, 65-66 and 87-89 are pending. Claims 4-6, 15, 17, 28, 30, 38, 40, 42, 55-56, 65-66 and 87-89 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-3 are under consideration.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schadt et al (Cell Reports, 29:1236-1248, 2019).
With respect to claim 1, Schadt et al disclose methods of detecting chromosomal instability in a tumor in a subject by obtaining one or more tissue sections of a tumor sample from a subject (“we analyzed colorectal adenocarcinoma resection specimens from 25 patients”; see pages 1241 and 1242); and measuring the degree of chromosomal instability present in the tumor sample by contacting the tumor sample with an anti-cGAS antibody and measuring the presence of cGAS+ micronuclei in the tumor sample (“we stained for cGAS” … “we specifically analyzed cGAS expression by tumor cells”; see page 1242). Schadt et al disclose that the art has “shown that chromosomal instability leads to micronuclei, increased amounts of cytoplasmic dsDNA, activation of the cGAS/STING pathway, and
increased metastasis” and that cytoplasmic DNA is sensed by cGAS (see abstract and page 1245).
With respect to claims 2 and 31, Schadt et al disclose that their methods further comprise quantifying the fraction of cGAS+ micronuclei/primary nuclei (“We first applied an algorithm to segment the tissue in tumor and stroma based on expression of PanCK and morphology (Figure 6B). We then determined which proportion of cancer cells expressed cGAS (Figure 6C) … We found that only 15 out of 151 tumor images contained >10%cGAS+ cancer cells”; see page 1242).
Accordingly, the reference anticipates the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by WO 2019/014246 A1 (Cantley et al, IDS).
With respect to claim 1, Cantley et al discloses a method for detecting chromosomal instability (detection in patients with chromosomal instabilities; abstract; figure 3A-3M) in a tumor in a subject (metastatic cancer patient; abstract), comprising: obtaining one or more tissue sections of a
tumor sample from a subject (obtaining a test sample where the test sample is from a patient and is from a tumor; page 14, lines 14-30); and measuring the degree of chromosomal instability present in the tumor (detection in patients with chromosomal instabilities; abstract; figure 3A-3M) sample by contacting the tumor sample with an anti-cGAS antibody (cell stained with anti-cGAS antibody; page 9, lines 5-7; figure 6A) and measuring the presence of cGAS+ micronuclei in the tumor sample (detecting micronuclei with cGAS localization; page 9, lines 6-7; figure 6B).
With respect to claims 2 and 32, Cantley et al disclose that their methods further comprise quantifying the fraction of cGAS+ micronuclei/primary nuclei (“FIG. 6B graphically illustrates the percentages of micronuclei with (cGAS+) or without (cGAS-) cGAS localization”; see page 9).
Accordingly, the reference anticipates the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRAD DUFFY whose telephone number is (571)272-9935. The examiner can normally be reached Mon-Fri.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
May 27, 2026
1 Claims 2 and 3 recite conditional language (“wherein a high degree of chromosomal instability in the tumor is detected when the fraction of cGAS+ micronuclei/primary nuclei is 10% or higher”). Consistent with MPEP § 2111.04 the broadest reasonable interpretation of the claim includes the step of quantifying the fraction of cGAS+ micronuclei/primary nuclei, whether or not the fraction of cGAS+ micronuclei/primary nuclei is 10% or higher. Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed (see MPEP § 2111.04 and Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016). However, it is further noted that the prior art does detect that 15 out of 151 tumor images contained >10% cGAS+ cancer cells.
2 Claims 2 and 3 recite conditional language (“wherein a high degree of chromosomal instability in the tumor is detected when the fraction of cGAS+ micronuclei/primary nuclei is 10% or higher”). Consistent with MPEP § 2111.04 the broadest reasonable interpretation of the claim includes the step of quantifying the fraction of cGAS+ micronuclei/primary nuclei, whether or not the fraction of cGAS+ micronuclei/primary nuclei is 10% or higher. Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed (see MPEP § 2111.04 and Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016). However, it is further noted that the prior art does detect >10% cGAS+ cancer cells in Figure 6B.
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